Sevelamer Carbonate is a crossolinked polymeric amine, it is the active ingredient in Renvela Tablets. Sevelamer Carbonate is indicated for the control of hyperphosphatamiea in patients with end-stage renal disease. T...Sevelamer Carbonate is a crossolinked polymeric amine, it is the active ingredient in Renvela Tablets. Sevelamer Carbonate is indicated for the control of hyperphosphatamiea in patients with end-stage renal disease. The binding parameter constants of Sevelamer Carbonate were determined using the Langmuir approximation for the dosage form at pH 4.0 and 7.0 by Ion Chromatography. An Ion Chromatogrpahy method has been developed to estimate free phosphate in in-vitro phosphate binding study of Sevelamer Carbonate Tablets. The method is selective and capable of detecting phosphate in the presence of placebo matrix. The method has been validated with a lower limit of quantitation of 0.2 mM for Phosphate. A linear response function was established in the range of concentrations 0.2 - 30.0 mM (r > 0.99) for Phosphate. The intra and inter day precision values for Phosphate met the acceptance as per Food and Drug Administrations guidelines. Phosphate was stable in the set of stability studies viz. bench-top and autosampler. The developed method was applied to in-vitro phosphate binding studies of Sevelamer Carbonate Tablets.展开更多
An ICP-OES method has been developed to estimate Calcium and Phosphorous in In vitro phosphate binding study of Eliphos Tablets. The method is selective and is capable of detecting calcium and phosphorous in the prese...An ICP-OES method has been developed to estimate Calcium and Phosphorous in In vitro phosphate binding study of Eliphos Tablets. The method is selective and is capable of detecting calcium and phosphorous in the presence of other trace elements. The method has been validated using RF power of 1500 watts, plasma flow of 15L/min, Nebuliser flow of 0.8 L/min and plasma view at radial mode for calcium and axial mode for phosphorus. The wavelength was monitored for calcium and phosphorous at 317.933 nm and 213.677 nm respectively. The method has been validated in terms of specificity, precision, linearity, accuracy, limit of quantification and ruggedness. The In vitro binding studies were performed for Eliphos Tablets at eight dif- ferent phosphate concentrations by incubating at 37.0?C and analysis was performed using the validated method to estimate free calcium and phosphorus. The objective of the study is to provide an alternate In vitro method to estimate the binding capacity of calcium acetate tablets to avoid the expensive in-vivo bio clinical studies.展开更多
Sevelamer Hydrochloride is a crossolinked polymeric amine;it is the active ingredient in Renagel Tablets. Sevelamer Hydrochloride is indicated for the control of hyperphosphatamiea in patients with end-stage renal dis...Sevelamer Hydrochloride is a crossolinked polymeric amine;it is the active ingredient in Renagel Tablets. Sevelamer Hydrochloride is indicated for the control of hyperphosphatamiea in patients with end-stage renal disease. The binding parameter constants of Sevelamer Hydrochloride were determined using the Langmuir approximation for the dosage form at pH 4.0 and 7.0 by Inductively Coupled Plasma-Optical Emission Spectrometry. An ICP-OES method has been developed to estimate free phosphate in In-Vitro phosphate binding study of Sevelamer HCl Tablets. The method is selective and capable of detecting phosphate in the presence of placebo matrix. The method has been validated with a lower limit of quantitation of 0.2 mM for Phosphate. A linear response function was established for the range of concentrations 0.2 - 25.0 mM (r > 0.99) for Phosphate. The intra and inter day precision values for Phosphate met the acceptance as per Food and Drug Administrations guidelines. Phosphate was stable in the set of stability studies viz. bench-top and autosampler. The developed method was applied to in-vitro phosphate binding studies of Sevelamer HCl Tablets.展开更多
文摘Sevelamer Carbonate is a crossolinked polymeric amine, it is the active ingredient in Renvela Tablets. Sevelamer Carbonate is indicated for the control of hyperphosphatamiea in patients with end-stage renal disease. The binding parameter constants of Sevelamer Carbonate were determined using the Langmuir approximation for the dosage form at pH 4.0 and 7.0 by Ion Chromatography. An Ion Chromatogrpahy method has been developed to estimate free phosphate in in-vitro phosphate binding study of Sevelamer Carbonate Tablets. The method is selective and capable of detecting phosphate in the presence of placebo matrix. The method has been validated with a lower limit of quantitation of 0.2 mM for Phosphate. A linear response function was established in the range of concentrations 0.2 - 30.0 mM (r > 0.99) for Phosphate. The intra and inter day precision values for Phosphate met the acceptance as per Food and Drug Administrations guidelines. Phosphate was stable in the set of stability studies viz. bench-top and autosampler. The developed method was applied to in-vitro phosphate binding studies of Sevelamer Carbonate Tablets.
文摘An ICP-OES method has been developed to estimate Calcium and Phosphorous in In vitro phosphate binding study of Eliphos Tablets. The method is selective and is capable of detecting calcium and phosphorous in the presence of other trace elements. The method has been validated using RF power of 1500 watts, plasma flow of 15L/min, Nebuliser flow of 0.8 L/min and plasma view at radial mode for calcium and axial mode for phosphorus. The wavelength was monitored for calcium and phosphorous at 317.933 nm and 213.677 nm respectively. The method has been validated in terms of specificity, precision, linearity, accuracy, limit of quantification and ruggedness. The In vitro binding studies were performed for Eliphos Tablets at eight dif- ferent phosphate concentrations by incubating at 37.0?C and analysis was performed using the validated method to estimate free calcium and phosphorus. The objective of the study is to provide an alternate In vitro method to estimate the binding capacity of calcium acetate tablets to avoid the expensive in-vivo bio clinical studies.
文摘Sevelamer Hydrochloride is a crossolinked polymeric amine;it is the active ingredient in Renagel Tablets. Sevelamer Hydrochloride is indicated for the control of hyperphosphatamiea in patients with end-stage renal disease. The binding parameter constants of Sevelamer Hydrochloride were determined using the Langmuir approximation for the dosage form at pH 4.0 and 7.0 by Inductively Coupled Plasma-Optical Emission Spectrometry. An ICP-OES method has been developed to estimate free phosphate in In-Vitro phosphate binding study of Sevelamer HCl Tablets. The method is selective and capable of detecting phosphate in the presence of placebo matrix. The method has been validated with a lower limit of quantitation of 0.2 mM for Phosphate. A linear response function was established for the range of concentrations 0.2 - 25.0 mM (r > 0.99) for Phosphate. The intra and inter day precision values for Phosphate met the acceptance as per Food and Drug Administrations guidelines. Phosphate was stable in the set of stability studies viz. bench-top and autosampler. The developed method was applied to in-vitro phosphate binding studies of Sevelamer HCl Tablets.
