CDRI compound no. 99/411 is a potent 1,2,4-trioxane antimalarial candidate drug under development at our Institute. An HPLC method for determination of CDRI 99/411 with its starting material and intermediates has been...CDRI compound no. 99/411 is a potent 1,2,4-trioxane antimalarial candidate drug under development at our Institute. An HPLC method for determination of CDRI 99/411 with its starting material and intermediates has been developed and validated for in process quality control and stability studies. The analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection （LOD） and lower limit of quantification （LLOQ） were determined according to International Conference on Harmonization ICH Q2（R1） guidelines. HPLC separation was achieved on a RP-select B Lichrosphere~ column （250 mm x 4 ram, 5 lam, Merck） using water containing 0.1% glacial acetic acid and acetonitrile as the mobile phase in a gradient elution. The eluents were monitored by a photo diode array detector at 245 and 275 nm. Based on signal to noise ratio of 3 and 10 the LOD of CDRI 99/411 was 0.55 μg/mL, while the LLOQ was 1.05 μg/mL. The calibration curves were linear in the range of 1.05- 68 μg/mL. Precision of the method was determined by inter- and intra-assay variations within the acceptable range.展开更多
Formal methods are the mathematically techniques and tools which are used at early stages of software development lifecycle processes. The utter need of using formal methods in safety critical system leads to accuracy...Formal methods are the mathematically techniques and tools which are used at early stages of software development lifecycle processes. The utter need of using formal methods in safety critical system leads to accuracy, consistency and correctness in proposed system. In safety critical real time application, requirements should be unambiguous and very accurate which can be achieved by using mathematical theorems. There is utter need to focus on the requirement phase which is the most critical phase of SDLC. This paper focuses on the use of Z notation for incorporating the accuracy, consistency, and eliminates ambiguity in safety critical system: Road Traffic Management System as a case study. The syntax, semantics, type checking and domain checking are further verified by using Z/EVES: a Z notation type checker tool.展开更多
基金Financial support to Shakti Deep Pachauri and Kiran Khandelwal from the Council of Scientifc and Industrial Research (CSIR)New DelhiIndiais gratefully acknowledged
文摘CDRI compound no. 99/411 is a potent 1,2,4-trioxane antimalarial candidate drug under development at our Institute. An HPLC method for determination of CDRI 99/411 with its starting material and intermediates has been developed and validated for in process quality control and stability studies. The analytical performance parameters such as linearity, precision, accuracy, specificity, limit of detection （LOD） and lower limit of quantification （LLOQ） were determined according to International Conference on Harmonization ICH Q2（R1） guidelines. HPLC separation was achieved on a RP-select B Lichrosphere~ column （250 mm x 4 ram, 5 lam, Merck） using water containing 0.1% glacial acetic acid and acetonitrile as the mobile phase in a gradient elution. The eluents were monitored by a photo diode array detector at 245 and 275 nm. Based on signal to noise ratio of 3 and 10 the LOD of CDRI 99/411 was 0.55 μg/mL, while the LLOQ was 1.05 μg/mL. The calibration curves were linear in the range of 1.05- 68 μg/mL. Precision of the method was determined by inter- and intra-assay variations within the acceptable range.
文摘Formal methods are the mathematically techniques and tools which are used at early stages of software development lifecycle processes. The utter need of using formal methods in safety critical system leads to accuracy, consistency and correctness in proposed system. In safety critical real time application, requirements should be unambiguous and very accurate which can be achieved by using mathematical theorems. There is utter need to focus on the requirement phase which is the most critical phase of SDLC. This paper focuses on the use of Z notation for incorporating the accuracy, consistency, and eliminates ambiguity in safety critical system: Road Traffic Management System as a case study. The syntax, semantics, type checking and domain checking are further verified by using Z/EVES: a Z notation type checker tool.
