In-vitro Equilibrium Phosphate Binding Study of Sevelamer Carbonate by UV-Vis Spectrophotometry
| Autor: | Theresia Weliana Kosasih, Uci Chilmi, Endah Sari, Prawitasari Cahyaningsih, Budi Prasaja, M. Maulana Syabani |
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| Rok vydání: | 2018 |
| Předmět: |
Chemistry
Pharmaceutical 030232 urology & nephrology Sevelamer Bioequivalence Sensitivity and Specificity Calcium Carbonate Phosphates 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Ultraviolet visible spectroscopy Spectrophotometry Drug Discovery medicine Drugs Generic 030212 general & internal medicine Chelating Agents Detection limit Active ingredient Chromatography medicine.diagnostic_test Chemistry General Medicine Phosphate Bioavailability Therapeutic Equivalency medicine.drug Tablets |
| Zdroj: | Drug research. 68(11) |
| ISSN: | 2194-9387 |
| Popis: | Sevelamer carbonate is a cross-linked polymeric amine; it is the active ingredient in Renvela® tablets. US FDA provides recommendation for demonstrating bioequivalence for the development of a generic product of sevelamer carbonte using in-vitro equilibrium binding study. A simple UV-vis spectrophotometry method was developed and validated for quantification of free phosphate to determine the binding parameter constant of sevelamer. The method validation demonstrated the specificity, limit of quantification, accuracy and precision of measurements. The validated method has been successfully used to analyze samples in in-vitro equilibrium binding study for demonstrating bioequivalence. |
| Databáze: | OpenAIRE |
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