A novel, simple, and sensitive Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for the quantification of process-related impurities and degradants, as well as the assay of Docetaxel. ...A novel, simple, and sensitive Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for the quantification of process-related impurities and degradants, as well as the assay of Docetaxel. The stability-indicating capability of the method was demonstrated through forced degradation studies and a comprehensive mass balance evaluation. Chromatographic separation was achieved using an ACQUITY UPLC BEH C18 column (100 × 2.1 mm, 1.7 µm), with gradient elution. The mobile phase A comprised a mixture of water, methanol, and acetonitrile (500:300:200, v/v/v), while mobile phase B was acetonitrile and water (800:200, v/v). The flow rate was set at 0.4 mL/min, with detection at 232 nm using a photodiode array detector. The method exhibited excellent performance, with a tailing factor of 1.10 for Docetaxel. The method was rigorously validated for precision, accuracy, linearity, LOD, LOQ, ruggedness, specificity, and robustness. Forced degradation studies confirmed the method’s suitability for stability analysis. Stability testing on the drug substance was conducted following ICH guidelines.展开更多
Background: The robustness is a measurement of an analytical chemical method and its ability to contain unaffected by little with deliberate variation of analytical chemical method parameters. The analytical chemical ...Background: The robustness is a measurement of an analytical chemical method and its ability to contain unaffected by little with deliberate variation of analytical chemical method parameters. The analytical chemical method variation parameters are based on pH variability of buffer solution of mobile phase, organic ratio composition changes, stationary phase (column) manufacture, brand name and lot number variation;flow rate variation and temperature variation of chromatographic system. The analytical chemical method for assay of Atropine Sulfate conducted for robustness evaluation. The typical variation considered for mobile phase organic ratio change, change of pH, change of temperature, change of flow rate, change of column etc. Purpose: The aim of this study is to develop a cost effective, short run time and robust analytical chemical method for the assay quantification of Atropine in Pharmaceutical Ophthalmic Solution. This will help to make analytical decisions quickly for research and development scientists as well as will help with quality control product release for patient consumption. This analytical method will help to meet the market demand through quick quality control test of Atropine Ophthalmic Solution and it is very easy for maintaining (GDP) good documentation practices within the shortest period of time. Method: HPLC method has been selected for developing superior method to Compendial method. Both the compendial HPLC method and developed HPLC method was run into the same HPLC system to prove the superiority of developed method. Sensitivity, precision, reproducibility, accuracy parameters were considered for superiority of method. Mobile phase ratio change, pH of buffer solution, change of stationary phase temperature, change of flow rate and change of column were taken into consideration for robustness study of the developed method. Results: The limit of quantitation (LOQ) of developed method was much low than the compendial method. The % RSD for the six sample assay of developed method was 0.4% where the % RSD of the compendial method was 1.2%. The reproducibility between two analysts was 100.4% for developed method on the contrary the compendial method was 98.4%.展开更多
This paper delves into Agile Development Methods in Software Engineering,contrasting them with the traditional Waterfall model and analyzing their efficiency.Agile methods,known for their adaptability and customer-cen...This paper delves into Agile Development Methods in Software Engineering,contrasting them with the traditional Waterfall model and analyzing their efficiency.Agile methods,known for their adaptability and customer-centric approach,have gained prominence in the fast-paced software development industry.These methods,including Scrum,Kanban,and Extreme Programming(XP),are characterized by iterative cycles,collaborative efforts,and a focus on rapid delivery and quality improvement.The paper compares these agile methodologies to the sequential and rigid Waterfall model,highlighting agile’s superior flexibility,adaptability,and responsiveness to changing requirements.It emphasizes the importance of customer involvement in agile processes,which leads to higher satisfaction and better alignment with user expectations.The analysis reveals that agile methods not only enhance the speed of delivery but also improve the overall quality of the software product.The paper concludes that agile methodologies are more effective in today's dynamic software development environment,providing a robust framework for managing complex projects and ensuring the delivery of high-quality,relevant software solutions.展开更多
Under the background of“new engineering”construction,software engineering teaching pays more attention to cultivating students’engineering practice and innovation ability.In view of the inconsistency between develo...Under the background of“new engineering”construction,software engineering teaching pays more attention to cultivating students’engineering practice and innovation ability.In view of the inconsistency between development and demand design,team division of labor,difficult measurement of individual contribution,single assessment method,and other problems in traditional practice teaching,this paper proposes that under the guidance of agile development methods,software engineering courses should adopt Scrum framework to organize course project practice,use agile collaboration platform to implement individual work,follow up experiment progress,and ensure effective project advancement.The statistical data of curriculum“diversity”assessment show that there is an obvious improvement effect on students’software engineering ability and quality.展开更多
A simple and rapid HPTLC analytical method has been developed and validated for the determination of Etanercept and Filgrastim in pure form and in marketed formulation. Both the drugs were chromatographed on silica ge...A simple and rapid HPTLC analytical method has been developed and validated for the determination of Etanercept and Filgrastim in pure form and in marketed formulation. Both the drugs were chromatographed on silica gel 60 F254s HPTLC plates, as stationary phase. The mobile phase optimized for Filgrastim and Etanercept was Water: n-butanol (7.5:2.5 v/v) and Isopropyl alcohol: water (6.5:4.5 v/v), respectively. The chromatogram obtained was scanned at 225 nm and 222 nm for filgrastim and etanercept which resulted in a retention factor of 0.45 ± 0.07 and 0.32 ± 0.03, respectively. The method was validated for parameters like linearity, accuracy, precision, specificity and robustness. Recovery studies were performed at three concentration levels, to demonstrate suitability, accuracy and precision of proposed method. Statistical analysis proved that the proposed method is accurate and reproducible with linearity in the range of 500 to 3000 ng/band for filgrastim and 200 to 1200 ng/band for etanercept. The limit of detection and limit of quantification for filgrastim was found to be 63.418 ng/band and 192.177 ng/band. For etanercept, LOD and LOQ were found to be 33.381 ng/band and 101.153 ng/band, respectively. The proposed method can be employed for the routine analysis of selected biosimilars.展开更多
Background: Impurities are not expected in the final pharmaceutical products. All impurities should be regulated in both drug substances and drug products in accordance with pharmacopeias and ICH guidelines. Three dif...Background: Impurities are not expected in the final pharmaceutical products. All impurities should be regulated in both drug substances and drug products in accordance with pharmacopeias and ICH guidelines. Three different types of impurities are generally available in the pharmaceutical’s product specification: organic impurities, inorganic impurities, and residual solvents. Residual solvents are organic volatile chemicals used or generated during the manufacturing of drug substances or drug products. Purpose: The aim of this study is to develop a cost-effective gas chromatographic method for the identification and quantification of some commonly used solvents—methanol, acetone, isopropyl alcohol (IPA), methylene chloride, ethyl acetate, tetrahydrofuran (THF), benzene, toluene, and pyridine—in pharmaceutical product manufacturing. This method will be able to identify and quantify the multiple solvents within a single gas chromatographic procedure. Method: A gas chromatography (GC) equipped with a headspace sampler and a flame ionization detector, and a column DB 624, 30-meter-long × 0.32-millimeter internal diameter, 1,8 μm-thick, Brand-Agilent was used to develop this method. The initial GC oven temperature was 40°C and held for 5 minutes. It was then increase to 80˚C at a rate of 2˚C per minute, followed by a further increase to 225˚C at a rate of 30˚C per minute, with a final hold at 225˚C for 10 minutes. Nitrogen was used as a carrier gas at a flow rate of 1.20 mL per minute. Dimethyl sulfoxide (DMSO) was selected as sample solvent. Results: The developed method is precise and specific. The percent RSD for the areas of six replicate injections of this gas chromatographic method was within 10.0 and the recovery result found within 80.0% to 120.0%.展开更多
Carbonate reservoirs worldwide are complex in structure,diverse in form,and highly heterogeneous.Based on these characteristics,the reservoir stimulation technologies and fluid flow characteristics of carbonate reserv...Carbonate reservoirs worldwide are complex in structure,diverse in form,and highly heterogeneous.Based on these characteristics,the reservoir stimulation technologies and fluid flow characteristics of carbonate reservoirs are briefly described in this study.The development methods and EOR technologies of carbonate reservoirs are systematically summarized,the relevant mechanisms are analyzed,and the application status of oil fields is catalogued.The challenges in the development of carbonate reservoirs are discussed,and future research directions are explored.In the current development processes of carbonate reservoirs,water flooding and gas flooding remain the primary means but are often prone to channeling problems.Chemical flooding is an effective method of tertiary oil recovery,but the harsh formation conditions require high-performance chemical agents.The application of emerging technologies can enhance the oil recovery efficiency and environmental friendliness to a certain extent,which is welcome in hard-to-recover areas such as heavy oil reservoirs,but the economic cost is often high.In future research on EOR technologies,flow field control and flow channel plugging will be the potential directions of traditional development methods,and the application of nanoparticles will revolutionize the chemical EOR methods.On the basis of diversified reservoir stimulation,combined with a variety of modern data processing schemes,multichannel EOR technologies are being developed to realize the systematic,intelligent,and cost-effective development of carbonate reservoirs.展开更多
A rapid GC-FID method was developed to simultaneously determine residual levels of triethylamine(TEA), 1,1,3,3-tetramethylguanidine(TMG), and diisopropylamine(DIPA) in the synthetic route of an active pharmaceutical i...A rapid GC-FID method was developed to simultaneously determine residual levels of triethylamine(TEA), 1,1,3,3-tetramethylguanidine(TMG), and diisopropylamine(DIPA) in the synthetic route of an active pharmaceutical ingredient(API). Due to the severe absorption of amines on GC stationary phases,GC columns with various stationary phases were evaluated for optimal peak shape and reproducibility.The final conditions used the Agilent CP-Volamine column to resolve the three amines in 12 min. Various inlet liners were also screened to further improve the sensitivity of the analysis. The Restek Siltek~? liner was selected to achieve the desired detectability for the method. The quantitation limits were 4, 3, and 4 mg/mL for TEA, DIPA, and TMG in the presence of API, respectively. All three amines showed good linearity(r > 0.999) and recoveries(> 90%) over the concentration range of 3 to 16 mg/mL. The testing of residual amines was initially performed at the penultimate stage of the synthesis. However, this work demonstrates that TMG can act as a proton sponge to react with salicylic acid, the counter ion of the penultimate, to form a volatile component that elutes at a different retention time. Consequently, in the final method, these three amines were monitored in the final API to circumvent the matrix interference.Key parameters of the method were qualified per method validation requirements in ICH guidelines. The method was successfully applied for batch testing during development and implemented as an inprocess control procedure at manufacturing sites.展开更多
The asymptotic development method is applied to analyze the free vibration of non-uniform axially functionally graded(AFG) beams, of which the governing equations are differential equations with variable coefficients....The asymptotic development method is applied to analyze the free vibration of non-uniform axially functionally graded(AFG) beams, of which the governing equations are differential equations with variable coefficients. By decomposing the variable flexural stiffness and mass per unit length into reference invariant and variant parts, the perturbation theory is introduced to obtain an approximate analytical formula of the natural frequencies of the non-uniform AFG beams with different boundary conditions.Furthermore, assuming polynomial distributions of Young's modulus and the mass density, the numerical results of the AFG beams with various taper ratios are obtained and compared with the published literature results. The discussion results illustrate that the proposed method yields an effective estimate of the first three order natural frequencies for the AFG tapered beams. However, the errors increase with the increase in the mode orders especially for the cases with variable heights. In brief, the asymptotic development method is verified to be simple and efficient to analytically study the free vibration of non-uniform AFG beams, and it could be used to analyze any tapered beams with an arbitrary varying cross width.展开更多
<strong>Context:</strong> Substandard and falsified medicines are circulating in low-income countries mostly without any control. We availed a simple and not expensive UV-Vis spectroscopic method to evalua...<strong>Context:</strong> Substandard and falsified medicines are circulating in low-income countries mostly without any control. We availed a simple and not expensive UV-Vis spectroscopic method to evaluate the quality of tramadol in Kisangani before and during the Covid-19 period. <strong>Methods:</strong> For the analytical quantitative method, an experimental design was applied to set up the optimal levels of the selected factors, namely, pH of dissolution medium, type of cuvette, and wavelength. Taking into account the capsule pharmaceutical formulation within 80 - 120 μg·mL<sup>-1</sup> concentration range, we analyzed 89 tramadol samples from pharmacies and hospitals of the six Kisangani municipalities. <strong>Results:</strong> pH showed a significant effect on absorbance, whereas quartz cuvette and wavelength did not. A typical 100 μg·mL<sup>-1</sup> tramadol solution gave an absorbance of 0.64 at 272 nm. Validation highlighted a matrix effect observed with a 6% bias. A correction factor of 0.9372 allowed to improve the accuracy profile, which were then totally included within the 10% acceptance limits. Quality control revealed that 25 samples out of 89 were not compliant in terms of manufacturing license, registration status in DRC and content as well. <strong>Conclusion:</strong> This study showed that the strengthening of analytical strategy in Kisangani is a need.展开更多
The oil oxidation characteristics of the whole temperature regions from 30 ℃ to 600 ℃ during oil reservoir air injection were revealed by experiments. The whole oil oxidation temperature regions were divided into fo...The oil oxidation characteristics of the whole temperature regions from 30 ℃ to 600 ℃ during oil reservoir air injection were revealed by experiments. The whole oil oxidation temperature regions were divided into four different parts: dissolving and inflation region, low temperature oxidation region, medium temperature oxidation region and high temperature oxidation region. The reaction mechanisms of different regions were explained. Based on the oil oxidation characteristics and filed tests results, light oil reservoirs air injection development methods were divided into two types: oxygen-reducing air flooding and air flooding;heavy oil reservoirs air injection in-situ combustion development methods were divided into two types: medium temperature in-situ combustion and high temperature in-situ combustion. When the reservoir temperature is lower than 120 ℃, oxygen-reducing air flooding should be used for light oil reservoir development. When the reservoir temperature is higher than 120 ℃, air flooding method should be used for light oil reservoir development. For a normal heavy oil reservoir, when the combustion front temperature is lower than 400 ℃, the development method is medium temperature in-situ combustion. For a heavy oil reservoir with high oil resin and asphalting contents, when the combustion front temperature is higher than 450 ℃, the development method at this condition is high temperature in-situ combustion. Ten years field tests of air injection carried out by PetroChina proved that air has advantages in technical, economical and gas source aspects compared with other gas agents for oilfield gas injection development. Air injection development can be used in low/super-low permeability light oil reservoirs, medium and high permeability light oil reservoirs and heavy oil reservoirs. Air is a very promising gas flooding agent.展开更多
The research was carried out for establishing a new reverse phase-HPLC stability indicating method for the quantification of Rucaparib. The experiment was determined on Waters HPLC instrument using 996 photo-diode arr...The research was carried out for establishing a new reverse phase-HPLC stability indicating method for the quantification of Rucaparib. The experiment was determined on Waters HPLC instrument using 996 photo-diode array detector. The separation was done by using symmetry C-18 ODS (25 cm × 0.46 cm internal diameter) 5 μm analytical column containing mobile phase of Phosphate buffer (0.02 M) and methanol [65:35% v/v] adjusted pH to 4.8 by adding dilute ortho phosphoric acid. The method was run at 1 ml·min<sup>-1</sup> at 286 nm detection. The drug was eluted at 5.484 min. After developing the method, it was assured for the intended use by validation which was done according to ICH Q2B guidelines. The analytical parameters checked were linearity, accuracy, repeatability, intermediate precision, limit of detection, limit of quantitation, ruggedness and robustness. It was observed that the response of the detector was linear in the range of 6 - 14 μg/ml with correlation coefficient of 0.999. The results of all the parameters were found to be within the acceptance criteria. The stability indicating assay method was established by using the samples generated by forced degradation process. The forced degradation was carried out by subjecting the drug to acid, alkali, thermal, oxidative and photolytic degradation and the results showed that the degradation products were successfully separated from the drug. Hence, this can be applied perfectly later for the analysis of quality of the rucaparib drug.展开更多
The research work was carried out for establishing a new Ultra Violet (UV)— Visible spectroscopy and Reverse phase-Ultra Fast Liquid Chromatography (RP-UFLC) method for the analysis and quantification of a biosimilar...The research work was carried out for establishing a new Ultra Violet (UV)— Visible spectroscopy and Reverse phase-Ultra Fast Liquid Chromatography (RP-UFLC) method for the analysis and quantification of a biosimilar drug, Filgrastim. Filgrastim or recombinant methionyl granulocyte colony stimulating factor (rGCSF) is a glycoprotein. It has a biological action essential for proliferation and differentiation of hematopoetic and progenitor cells. The UV and RP-UFLC work was carried on a Shimadzu UV1800 Spectrophotometer and Shimadzu Prominence LC-20AD UFLC systems, respectively. The <i>λ</i><sub>max</sub> of filgrastim was found to be 215 nm. The correlation coefficient by UV spectroscopy was found to be 0.9994 for the concentration range of 1 to 3 μg/ml in double distilled water. The Reverse phase UFLC was done by using Phenomenex C4 (25 cm × 0.46 cm internal diameter) 15 μ, 300 A° analytical column. The optimized mobile phase for binary elution was Acetonitrile and double distilled water (80:20) with a flow rate of 1 ml/min. The retention time of drug was at 3.2 min. It was observed that the response of the detector was linear in the range of 5 - 15 μg/ml with correlation coefficient value of 0.999. After developing the methods, it was assured for the intended use by validation of the analytical parameters like linearity, accuracy, precision, limit of detection, limit of quantitation, ruggedness and robustness. The results of all the parameters for both the methods were found to be within the acceptance criteria as per the International Council for Harmonisation (ICH) guidelines.展开更多
The matters of equipment optimization development are usually discrete,fuzzy and non-quantitative.It is difficult directly to optimize the equipment development with a mathematical model.A set of methods for designing...The matters of equipment optimization development are usually discrete,fuzzy and non-quantitative.It is difficult directly to optimize the equipment development with a mathematical model.A set of methods for designing the equipment optimization development with six dimensions and eight main elements is established based on the theory and method of standardization.The top-tier design space of systematic development of equipment is built up by the relations of basic models,series and model spectrums.The relations of time and space for equipment optimization development are established.The design processes of a six dimension systematic space are expounded.The connotation of each plan in the main system space is analyzed.A design method for an entire equipment is established with standardization theory.The coordinating design methods of equipment technical system and the optimization design methods of equipment integration are discussed.The design methods for universalization and serialization of components and parts are established.The design methods of equipment optimization development highlight the relations of the basic model of platform,the serialization of platform basic models,the modularization of equipment functions,the model spectrum of variant equipment,and the universalization and serialization of components and parts.展开更多
Generally, the sequence decision of the development and utilization of Chinese mineral resources is based on national and provincial overall plan of the mineral resources. Such plan usually cannot reflect the relative...Generally, the sequence decision of the development and utilization of Chinese mineral resources is based on national and provincial overall plan of the mineral resources. Such plan usually cannot reflect the relative size of the suitability of the development and utilization of mineral resources. To solve the problem, the paper has selected the gift condition, the market condition, the technological condition,socio-economic condition and environmental condition as the starting-points to analyze the influential factors of the priority-sequence of mineral resources' development and utilization. The above 5 conditions are further specified into 9 evaluative indicators to establish an evaluation indicator system. At last,we propose a decision model of the priority sequence based on grey relational analysis method, and figure out the observation objects by the suitability index of development. Finally, the mineral resources of a certain province in China were analyzed as an example. The calculation results indicate that silver(2.0057), coal(1.9955), zinc(1.9442), cement limestone(1.9077), solvent limestone(1.5624) and other minerals in the province are suitable for development and utilization.展开更多
Microsatellite marker （or Simple Sequence Repeate, SSR） is a marker technology based on DNA molecular length poly morphism. It is also one of the most commonly used molecular markers. Traditional SSR marker developm...Microsatellite marker （or Simple Sequence Repeate, SSR） is a marker technology based on DNA molecular length poly morphism. It is also one of the most commonly used molecular markers. Traditional SSR marker development methods are relatively time-consuming and mostly relying on the known genome sequence information while recently developed methods of SSR marker based on RAPD, ISSR-PCR SSR, the use of hybrid options, sequence tag SSR library access and screening EST-SSR have been widely used. This paper gave an overview of the methods mentioned above for the development of SSR markers.展开更多
Linux-based Platform for Open Architecture Controller ( POAC ), a new open architecture controller and its modular developing method are discussed. POAC divides the application software of controller into the developi...Linux-based Platform for Open Architecture Controller ( POAC ), a new open architecture controller and its modular developing method are discussed. POAC divides the application software of controller into the developing system and the application system. In the developing system, PAOC abstracts a series of function modules with unified data interface and function interface. In the application system, POAC defines the model of the architecture module, realizing the interoperability and interchangeability between the architecture modules. The modular developing method entities the users to make up an application system with some architecture modules, which consist of a set of function modules. The modular developing method decreases the developing time from the standard of controller architecture to the product.展开更多
This paper put forward a framework of artificial intelligence (AI) for app;ication of aerial photograph. The framwork contains structures of knowledge base and inference mechanism.The functions of framework about how ...This paper put forward a framework of artificial intelligence (AI) for app;ication of aerial photograph. The framwork contains structures of knowledge base and inference mechanism.The functions of framework about how to convert expert’s knowledge into logical rules and how to inference using the rules wer discussed. The regeneraion pltring of fired land in Dwi’an Mountains area was taken as an example to have a ditail discuss on the contation of knowledge base and the steps of inference mechaism. the program was written using the basic langUae and the running result proyed tha the software can take the place of expert’s work with high efficiellcy.展开更多
The research was carried out to establish a new reverse phase-HPLC stability indicating method for quantifying Bimatoprost & Timolol in ophthalmic solution. The experiment of Bimatoprost & Timolol in ophthalmi...The research was carried out to establish a new reverse phase-HPLC stability indicating method for quantifying Bimatoprost & Timolol in ophthalmic solution. The experiment of Bimatoprost & Timolol in ophthalmic solution method development was determined on Waters HPLC instrument using a UV Detector. The separation was done by using L11, Zorbex SB phenyl (4.6 mm × 250 mm internal diameter) 5 μm analytical column, containing mobile phase of Phosphate buffer (0.02 M), methanol, and acetonitrile [50:30:20 % v/v]. The method was run at 1 ml·min<sup>-1</sup> at 210 nm for Bimatoprost and 295 nm for Timolol for detection. The drug was eluted at 10.81 min for Bimatoprost and 3.77 min for Timolol. After developing the method, it was assured for the intended use by validation, which was done according to ICH Q2B guidelines. The analytical parameters checked were Specificity/Selectivity, linearity, Range, accuracy, ruggedness, and robustness. It was observed that the response of the detector was linear in the range of 6 - 18 μg/ml with a correlation coefficient of 0.999. The results of all the parameters were found to be within the acceptance criteria. The stability-indicating assay method was established by using the samples generated by the forced degradation process. The forced degradation was carried out by subjecting the drug to acid, alkali, thermal, oxidative, and photolytic degradation, and the results showed that the degradation products were successfully separated from the drug. Hence, this can be applied perfectly later for the quantitative analysis of Bimatoprost 0.3% + Timolol 0.5% Ophthalmic Solution drugs for pharmaceutical use. Currently, there is no official method for Bimatoprost & Timolol combination products in USP or BP. Available research work related to single Bimatoprost or Timolol products was not suitable for testing Bimatoprost and Timolol combination drugs. Additionally, there is no stability-indicating method to test Bimatoprost & Timolol combination products which insist us to do research and develop a new reverse phase-HPLC indicating method which will be faster and more accurate.展开更多
Detection of drugs in hair has become popular in recent years. The significantly long drug detection window (months) in hair has allowed the retrospective investigation and measurement of past consumption of drug. As ...Detection of drugs in hair has become popular in recent years. The significantly long drug detection window (months) in hair has allowed the retrospective investigation and measurement of past consumption of drug. As the majority of drugs are basic, an extraction method was developed based on a methanolic solution for detection of basic/weak basic drugs in hair. It was compared with alkaline digestion (NaOH) followed by LLE. A filtration step with filtration vials was added and their materials were compared. After filtration, extracts were injected directly onto a C18 column coupled to Sciex ABI 2000 MSMS. The mobile phase was 50% methanol, 0.1% formic acid and 2 mM ammonium acetate (isocratic). Both methods were compared by applying them to real samples. Results showed that calibration was linear with r2 of 0.991-0.999 for 20 tested analytes. The matrix effect was assessed to be between 91.4%- 110.2% for 18 analytes. PTFE filter material showed better recoveries over the GMF and PVDF based filters. Stability of analytes during extraction in general was better with methanolic incubation rather than alkaline digestion. With regard to real sample recovery, 6 out of 10 analytes recovered better with alkaline digestion. In conclusion, the methanolic method is capable of extracting most basic drugs in hair samples but only part of the total incorporated drug. Therefore, these results suggest that a combination of both methods (methanolic and alkaline extractions) in hair sample processing for general detection of basic and weak basic drugs may produce better results. However, not all basic drugs are stable under alkaline digestion.展开更多
文摘A novel, simple, and sensitive Ultra Performance Liquid Chromatography (UPLC) method was developed and validated for the quantification of process-related impurities and degradants, as well as the assay of Docetaxel. The stability-indicating capability of the method was demonstrated through forced degradation studies and a comprehensive mass balance evaluation. Chromatographic separation was achieved using an ACQUITY UPLC BEH C18 column (100 × 2.1 mm, 1.7 µm), with gradient elution. The mobile phase A comprised a mixture of water, methanol, and acetonitrile (500:300:200, v/v/v), while mobile phase B was acetonitrile and water (800:200, v/v). The flow rate was set at 0.4 mL/min, with detection at 232 nm using a photodiode array detector. The method exhibited excellent performance, with a tailing factor of 1.10 for Docetaxel. The method was rigorously validated for precision, accuracy, linearity, LOD, LOQ, ruggedness, specificity, and robustness. Forced degradation studies confirmed the method’s suitability for stability analysis. Stability testing on the drug substance was conducted following ICH guidelines.
文摘Background: The robustness is a measurement of an analytical chemical method and its ability to contain unaffected by little with deliberate variation of analytical chemical method parameters. The analytical chemical method variation parameters are based on pH variability of buffer solution of mobile phase, organic ratio composition changes, stationary phase (column) manufacture, brand name and lot number variation;flow rate variation and temperature variation of chromatographic system. The analytical chemical method for assay of Atropine Sulfate conducted for robustness evaluation. The typical variation considered for mobile phase organic ratio change, change of pH, change of temperature, change of flow rate, change of column etc. Purpose: The aim of this study is to develop a cost effective, short run time and robust analytical chemical method for the assay quantification of Atropine in Pharmaceutical Ophthalmic Solution. This will help to make analytical decisions quickly for research and development scientists as well as will help with quality control product release for patient consumption. This analytical method will help to meet the market demand through quick quality control test of Atropine Ophthalmic Solution and it is very easy for maintaining (GDP) good documentation practices within the shortest period of time. Method: HPLC method has been selected for developing superior method to Compendial method. Both the compendial HPLC method and developed HPLC method was run into the same HPLC system to prove the superiority of developed method. Sensitivity, precision, reproducibility, accuracy parameters were considered for superiority of method. Mobile phase ratio change, pH of buffer solution, change of stationary phase temperature, change of flow rate and change of column were taken into consideration for robustness study of the developed method. Results: The limit of quantitation (LOQ) of developed method was much low than the compendial method. The % RSD for the six sample assay of developed method was 0.4% where the % RSD of the compendial method was 1.2%. The reproducibility between two analysts was 100.4% for developed method on the contrary the compendial method was 98.4%.
文摘This paper delves into Agile Development Methods in Software Engineering,contrasting them with the traditional Waterfall model and analyzing their efficiency.Agile methods,known for their adaptability and customer-centric approach,have gained prominence in the fast-paced software development industry.These methods,including Scrum,Kanban,and Extreme Programming(XP),are characterized by iterative cycles,collaborative efforts,and a focus on rapid delivery and quality improvement.The paper compares these agile methodologies to the sequential and rigid Waterfall model,highlighting agile’s superior flexibility,adaptability,and responsiveness to changing requirements.It emphasizes the importance of customer involvement in agile processes,which leads to higher satisfaction and better alignment with user expectations.The analysis reveals that agile methods not only enhance the speed of delivery but also improve the overall quality of the software product.The paper concludes that agile methodologies are more effective in today's dynamic software development environment,providing a robust framework for managing complex projects and ensuring the delivery of high-quality,relevant software solutions.
文摘Under the background of“new engineering”construction,software engineering teaching pays more attention to cultivating students’engineering practice and innovation ability.In view of the inconsistency between development and demand design,team division of labor,difficult measurement of individual contribution,single assessment method,and other problems in traditional practice teaching,this paper proposes that under the guidance of agile development methods,software engineering courses should adopt Scrum framework to organize course project practice,use agile collaboration platform to implement individual work,follow up experiment progress,and ensure effective project advancement.The statistical data of curriculum“diversity”assessment show that there is an obvious improvement effect on students’software engineering ability and quality.
文摘A simple and rapid HPTLC analytical method has been developed and validated for the determination of Etanercept and Filgrastim in pure form and in marketed formulation. Both the drugs were chromatographed on silica gel 60 F254s HPTLC plates, as stationary phase. The mobile phase optimized for Filgrastim and Etanercept was Water: n-butanol (7.5:2.5 v/v) and Isopropyl alcohol: water (6.5:4.5 v/v), respectively. The chromatogram obtained was scanned at 225 nm and 222 nm for filgrastim and etanercept which resulted in a retention factor of 0.45 ± 0.07 and 0.32 ± 0.03, respectively. The method was validated for parameters like linearity, accuracy, precision, specificity and robustness. Recovery studies were performed at three concentration levels, to demonstrate suitability, accuracy and precision of proposed method. Statistical analysis proved that the proposed method is accurate and reproducible with linearity in the range of 500 to 3000 ng/band for filgrastim and 200 to 1200 ng/band for etanercept. The limit of detection and limit of quantification for filgrastim was found to be 63.418 ng/band and 192.177 ng/band. For etanercept, LOD and LOQ were found to be 33.381 ng/band and 101.153 ng/band, respectively. The proposed method can be employed for the routine analysis of selected biosimilars.
文摘Background: Impurities are not expected in the final pharmaceutical products. All impurities should be regulated in both drug substances and drug products in accordance with pharmacopeias and ICH guidelines. Three different types of impurities are generally available in the pharmaceutical’s product specification: organic impurities, inorganic impurities, and residual solvents. Residual solvents are organic volatile chemicals used or generated during the manufacturing of drug substances or drug products. Purpose: The aim of this study is to develop a cost-effective gas chromatographic method for the identification and quantification of some commonly used solvents—methanol, acetone, isopropyl alcohol (IPA), methylene chloride, ethyl acetate, tetrahydrofuran (THF), benzene, toluene, and pyridine—in pharmaceutical product manufacturing. This method will be able to identify and quantify the multiple solvents within a single gas chromatographic procedure. Method: A gas chromatography (GC) equipped with a headspace sampler and a flame ionization detector, and a column DB 624, 30-meter-long × 0.32-millimeter internal diameter, 1,8 μm-thick, Brand-Agilent was used to develop this method. The initial GC oven temperature was 40°C and held for 5 minutes. It was then increase to 80˚C at a rate of 2˚C per minute, followed by a further increase to 225˚C at a rate of 30˚C per minute, with a final hold at 225˚C for 10 minutes. Nitrogen was used as a carrier gas at a flow rate of 1.20 mL per minute. Dimethyl sulfoxide (DMSO) was selected as sample solvent. Results: The developed method is precise and specific. The percent RSD for the areas of six replicate injections of this gas chromatographic method was within 10.0 and the recovery result found within 80.0% to 120.0%.
基金supported by the Innovation Project for Graduates in UPC(Grant YCX2019016)the National Natural Science Foundation of China(Nos.51774306 and 51974346)+1 种基金the Science and Technology Support Plan for Youth Innovation of University in Shandong Province under Grant 2019KJH002the Major Scientific and Technological Projects of CNPC under Grant ZD2019-183-008。
文摘Carbonate reservoirs worldwide are complex in structure,diverse in form,and highly heterogeneous.Based on these characteristics,the reservoir stimulation technologies and fluid flow characteristics of carbonate reservoirs are briefly described in this study.The development methods and EOR technologies of carbonate reservoirs are systematically summarized,the relevant mechanisms are analyzed,and the application status of oil fields is catalogued.The challenges in the development of carbonate reservoirs are discussed,and future research directions are explored.In the current development processes of carbonate reservoirs,water flooding and gas flooding remain the primary means but are often prone to channeling problems.Chemical flooding is an effective method of tertiary oil recovery,but the harsh formation conditions require high-performance chemical agents.The application of emerging technologies can enhance the oil recovery efficiency and environmental friendliness to a certain extent,which is welcome in hard-to-recover areas such as heavy oil reservoirs,but the economic cost is often high.In future research on EOR technologies,flow field control and flow channel plugging will be the potential directions of traditional development methods,and the application of nanoparticles will revolutionize the chemical EOR methods.On the basis of diversified reservoir stimulation,combined with a variety of modern data processing schemes,multichannel EOR technologies are being developed to realize the systematic,intelligent,and cost-effective development of carbonate reservoirs.
文摘A rapid GC-FID method was developed to simultaneously determine residual levels of triethylamine(TEA), 1,1,3,3-tetramethylguanidine(TMG), and diisopropylamine(DIPA) in the synthetic route of an active pharmaceutical ingredient(API). Due to the severe absorption of amines on GC stationary phases,GC columns with various stationary phases were evaluated for optimal peak shape and reproducibility.The final conditions used the Agilent CP-Volamine column to resolve the three amines in 12 min. Various inlet liners were also screened to further improve the sensitivity of the analysis. The Restek Siltek~? liner was selected to achieve the desired detectability for the method. The quantitation limits were 4, 3, and 4 mg/mL for TEA, DIPA, and TMG in the presence of API, respectively. All three amines showed good linearity(r > 0.999) and recoveries(> 90%) over the concentration range of 3 to 16 mg/mL. The testing of residual amines was initially performed at the penultimate stage of the synthesis. However, this work demonstrates that TMG can act as a proton sponge to react with salicylic acid, the counter ion of the penultimate, to form a volatile component that elutes at a different retention time. Consequently, in the final method, these three amines were monitored in the final API to circumvent the matrix interference.Key parameters of the method were qualified per method validation requirements in ICH guidelines. The method was successfully applied for batch testing during development and implemented as an inprocess control procedure at manufacturing sites.
基金Project supported by the National Natural Science Foundation of China(No.11672008)
文摘The asymptotic development method is applied to analyze the free vibration of non-uniform axially functionally graded(AFG) beams, of which the governing equations are differential equations with variable coefficients. By decomposing the variable flexural stiffness and mass per unit length into reference invariant and variant parts, the perturbation theory is introduced to obtain an approximate analytical formula of the natural frequencies of the non-uniform AFG beams with different boundary conditions.Furthermore, assuming polynomial distributions of Young's modulus and the mass density, the numerical results of the AFG beams with various taper ratios are obtained and compared with the published literature results. The discussion results illustrate that the proposed method yields an effective estimate of the first three order natural frequencies for the AFG tapered beams. However, the errors increase with the increase in the mode orders especially for the cases with variable heights. In brief, the asymptotic development method is verified to be simple and efficient to analytically study the free vibration of non-uniform AFG beams, and it could be used to analyze any tapered beams with an arbitrary varying cross width.
文摘<strong>Context:</strong> Substandard and falsified medicines are circulating in low-income countries mostly without any control. We availed a simple and not expensive UV-Vis spectroscopic method to evaluate the quality of tramadol in Kisangani before and during the Covid-19 period. <strong>Methods:</strong> For the analytical quantitative method, an experimental design was applied to set up the optimal levels of the selected factors, namely, pH of dissolution medium, type of cuvette, and wavelength. Taking into account the capsule pharmaceutical formulation within 80 - 120 μg·mL<sup>-1</sup> concentration range, we analyzed 89 tramadol samples from pharmacies and hospitals of the six Kisangani municipalities. <strong>Results:</strong> pH showed a significant effect on absorbance, whereas quartz cuvette and wavelength did not. A typical 100 μg·mL<sup>-1</sup> tramadol solution gave an absorbance of 0.64 at 272 nm. Validation highlighted a matrix effect observed with a 6% bias. A correction factor of 0.9372 allowed to improve the accuracy profile, which were then totally included within the 10% acceptance limits. Quality control revealed that 25 samples out of 89 were not compliant in terms of manufacturing license, registration status in DRC and content as well. <strong>Conclusion:</strong> This study showed that the strengthening of analytical strategy in Kisangani is a need.
文摘The oil oxidation characteristics of the whole temperature regions from 30 ℃ to 600 ℃ during oil reservoir air injection were revealed by experiments. The whole oil oxidation temperature regions were divided into four different parts: dissolving and inflation region, low temperature oxidation region, medium temperature oxidation region and high temperature oxidation region. The reaction mechanisms of different regions were explained. Based on the oil oxidation characteristics and filed tests results, light oil reservoirs air injection development methods were divided into two types: oxygen-reducing air flooding and air flooding;heavy oil reservoirs air injection in-situ combustion development methods were divided into two types: medium temperature in-situ combustion and high temperature in-situ combustion. When the reservoir temperature is lower than 120 ℃, oxygen-reducing air flooding should be used for light oil reservoir development. When the reservoir temperature is higher than 120 ℃, air flooding method should be used for light oil reservoir development. For a normal heavy oil reservoir, when the combustion front temperature is lower than 400 ℃, the development method is medium temperature in-situ combustion. For a heavy oil reservoir with high oil resin and asphalting contents, when the combustion front temperature is higher than 450 ℃, the development method at this condition is high temperature in-situ combustion. Ten years field tests of air injection carried out by PetroChina proved that air has advantages in technical, economical and gas source aspects compared with other gas agents for oilfield gas injection development. Air injection development can be used in low/super-low permeability light oil reservoirs, medium and high permeability light oil reservoirs and heavy oil reservoirs. Air is a very promising gas flooding agent.
文摘The research was carried out for establishing a new reverse phase-HPLC stability indicating method for the quantification of Rucaparib. The experiment was determined on Waters HPLC instrument using 996 photo-diode array detector. The separation was done by using symmetry C-18 ODS (25 cm × 0.46 cm internal diameter) 5 μm analytical column containing mobile phase of Phosphate buffer (0.02 M) and methanol [65:35% v/v] adjusted pH to 4.8 by adding dilute ortho phosphoric acid. The method was run at 1 ml·min<sup>-1</sup> at 286 nm detection. The drug was eluted at 5.484 min. After developing the method, it was assured for the intended use by validation which was done according to ICH Q2B guidelines. The analytical parameters checked were linearity, accuracy, repeatability, intermediate precision, limit of detection, limit of quantitation, ruggedness and robustness. It was observed that the response of the detector was linear in the range of 6 - 14 μg/ml with correlation coefficient of 0.999. The results of all the parameters were found to be within the acceptance criteria. The stability indicating assay method was established by using the samples generated by forced degradation process. The forced degradation was carried out by subjecting the drug to acid, alkali, thermal, oxidative and photolytic degradation and the results showed that the degradation products were successfully separated from the drug. Hence, this can be applied perfectly later for the analysis of quality of the rucaparib drug.
文摘The research work was carried out for establishing a new Ultra Violet (UV)— Visible spectroscopy and Reverse phase-Ultra Fast Liquid Chromatography (RP-UFLC) method for the analysis and quantification of a biosimilar drug, Filgrastim. Filgrastim or recombinant methionyl granulocyte colony stimulating factor (rGCSF) is a glycoprotein. It has a biological action essential for proliferation and differentiation of hematopoetic and progenitor cells. The UV and RP-UFLC work was carried on a Shimadzu UV1800 Spectrophotometer and Shimadzu Prominence LC-20AD UFLC systems, respectively. The <i>λ</i><sub>max</sub> of filgrastim was found to be 215 nm. The correlation coefficient by UV spectroscopy was found to be 0.9994 for the concentration range of 1 to 3 μg/ml in double distilled water. The Reverse phase UFLC was done by using Phenomenex C4 (25 cm × 0.46 cm internal diameter) 15 μ, 300 A° analytical column. The optimized mobile phase for binary elution was Acetonitrile and double distilled water (80:20) with a flow rate of 1 ml/min. The retention time of drug was at 3.2 min. It was observed that the response of the detector was linear in the range of 5 - 15 μg/ml with correlation coefficient value of 0.999. After developing the methods, it was assured for the intended use by validation of the analytical parameters like linearity, accuracy, precision, limit of detection, limit of quantitation, ruggedness and robustness. The results of all the parameters for both the methods were found to be within the acceptance criteria as per the International Council for Harmonisation (ICH) guidelines.
文摘The matters of equipment optimization development are usually discrete,fuzzy and non-quantitative.It is difficult directly to optimize the equipment development with a mathematical model.A set of methods for designing the equipment optimization development with six dimensions and eight main elements is established based on the theory and method of standardization.The top-tier design space of systematic development of equipment is built up by the relations of basic models,series and model spectrums.The relations of time and space for equipment optimization development are established.The design processes of a six dimension systematic space are expounded.The connotation of each plan in the main system space is analyzed.A design method for an entire equipment is established with standardization theory.The coordinating design methods of equipment technical system and the optimization design methods of equipment integration are discussed.The design methods for universalization and serialization of components and parts are established.The design methods of equipment optimization development highlight the relations of the basic model of platform,the serialization of platform basic models,the modularization of equipment functions,the model spectrum of variant equipment,and the universalization and serialization of components and parts.
基金Financial support from the key project of the National Natural Science Foundation of China(No.71273118)is gratefully acknowledged
文摘Generally, the sequence decision of the development and utilization of Chinese mineral resources is based on national and provincial overall plan of the mineral resources. Such plan usually cannot reflect the relative size of the suitability of the development and utilization of mineral resources. To solve the problem, the paper has selected the gift condition, the market condition, the technological condition,socio-economic condition and environmental condition as the starting-points to analyze the influential factors of the priority-sequence of mineral resources' development and utilization. The above 5 conditions are further specified into 9 evaluative indicators to establish an evaluation indicator system. At last,we propose a decision model of the priority sequence based on grey relational analysis method, and figure out the observation objects by the suitability index of development. Finally, the mineral resources of a certain province in China were analyzed as an example. The calculation results indicate that silver(2.0057), coal(1.9955), zinc(1.9442), cement limestone(1.9077), solvent limestone(1.5624) and other minerals in the province are suitable for development and utilization.
文摘Microsatellite marker （or Simple Sequence Repeate, SSR） is a marker technology based on DNA molecular length poly morphism. It is also one of the most commonly used molecular markers. Traditional SSR marker development methods are relatively time-consuming and mostly relying on the known genome sequence information while recently developed methods of SSR marker based on RAPD, ISSR-PCR SSR, the use of hybrid options, sequence tag SSR library access and screening EST-SSR have been widely used. This paper gave an overview of the methods mentioned above for the development of SSR markers.
基金Shanghai Science and Technology Development Foundation (995107017)
文摘Linux-based Platform for Open Architecture Controller ( POAC ), a new open architecture controller and its modular developing method are discussed. POAC divides the application software of controller into the developing system and the application system. In the developing system, PAOC abstracts a series of function modules with unified data interface and function interface. In the application system, POAC defines the model of the architecture module, realizing the interoperability and interchangeability between the architecture modules. The modular developing method entities the users to make up an application system with some architecture modules, which consist of a set of function modules. The modular developing method decreases the developing time from the standard of controller architecture to the product.
文摘This paper put forward a framework of artificial intelligence (AI) for app;ication of aerial photograph. The framwork contains structures of knowledge base and inference mechanism.The functions of framework about how to convert expert’s knowledge into logical rules and how to inference using the rules wer discussed. The regeneraion pltring of fired land in Dwi’an Mountains area was taken as an example to have a ditail discuss on the contation of knowledge base and the steps of inference mechaism. the program was written using the basic langUae and the running result proyed tha the software can take the place of expert’s work with high efficiellcy.
文摘The research was carried out to establish a new reverse phase-HPLC stability indicating method for quantifying Bimatoprost & Timolol in ophthalmic solution. The experiment of Bimatoprost & Timolol in ophthalmic solution method development was determined on Waters HPLC instrument using a UV Detector. The separation was done by using L11, Zorbex SB phenyl (4.6 mm × 250 mm internal diameter) 5 μm analytical column, containing mobile phase of Phosphate buffer (0.02 M), methanol, and acetonitrile [50:30:20 % v/v]. The method was run at 1 ml·min<sup>-1</sup> at 210 nm for Bimatoprost and 295 nm for Timolol for detection. The drug was eluted at 10.81 min for Bimatoprost and 3.77 min for Timolol. After developing the method, it was assured for the intended use by validation, which was done according to ICH Q2B guidelines. The analytical parameters checked were Specificity/Selectivity, linearity, Range, accuracy, ruggedness, and robustness. It was observed that the response of the detector was linear in the range of 6 - 18 μg/ml with a correlation coefficient of 0.999. The results of all the parameters were found to be within the acceptance criteria. The stability-indicating assay method was established by using the samples generated by the forced degradation process. The forced degradation was carried out by subjecting the drug to acid, alkali, thermal, oxidative, and photolytic degradation, and the results showed that the degradation products were successfully separated from the drug. Hence, this can be applied perfectly later for the quantitative analysis of Bimatoprost 0.3% + Timolol 0.5% Ophthalmic Solution drugs for pharmaceutical use. Currently, there is no official method for Bimatoprost & Timolol combination products in USP or BP. Available research work related to single Bimatoprost or Timolol products was not suitable for testing Bimatoprost and Timolol combination drugs. Additionally, there is no stability-indicating method to test Bimatoprost & Timolol combination products which insist us to do research and develop a new reverse phase-HPLC indicating method which will be faster and more accurate.
文摘Detection of drugs in hair has become popular in recent years. The significantly long drug detection window (months) in hair has allowed the retrospective investigation and measurement of past consumption of drug. As the majority of drugs are basic, an extraction method was developed based on a methanolic solution for detection of basic/weak basic drugs in hair. It was compared with alkaline digestion (NaOH) followed by LLE. A filtration step with filtration vials was added and their materials were compared. After filtration, extracts were injected directly onto a C18 column coupled to Sciex ABI 2000 MSMS. The mobile phase was 50% methanol, 0.1% formic acid and 2 mM ammonium acetate (isocratic). Both methods were compared by applying them to real samples. Results showed that calibration was linear with r2 of 0.991-0.999 for 20 tested analytes. The matrix effect was assessed to be between 91.4%- 110.2% for 18 analytes. PTFE filter material showed better recoveries over the GMF and PVDF based filters. Stability of analytes during extraction in general was better with methanolic incubation rather than alkaline digestion. With regard to real sample recovery, 6 out of 10 analytes recovered better with alkaline digestion. In conclusion, the methanolic method is capable of extracting most basic drugs in hair samples but only part of the total incorporated drug. Therefore, these results suggest that a combination of both methods (methanolic and alkaline extractions) in hair sample processing for general detection of basic and weak basic drugs may produce better results. However, not all basic drugs are stable under alkaline digestion.
