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Simple, accurate and sensitive liquid chromatographic methods has been developed for the assay, dissolution of ibandronate sodium drug substance in tablet dosage form. The separation was achieved on various columns at ambient temperature. The analytes were monitored by PDA and RID detector. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolytic, thermal and humidity degradation. Considerable degradation was achieved under several conditions. Mass balance was demonstrated in all stress conditions. The method was validated for specificity, precision,…mehr

Produktbeschreibung
Simple, accurate and sensitive liquid chromatographic methods has been developed for the assay, dissolution of ibandronate sodium drug substance in tablet dosage form. The separation was achieved on various columns at ambient temperature. The analytes were monitored by PDA and RID detector. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolytic, thermal and humidity degradation. Considerable degradation was achieved under several conditions. Mass balance was demonstrated in all stress conditions. The method was validated for specificity, precision, linearity, solution stability and accuracy. The average recoveries for ibandronate were in the range of 99.0-102.0% and the method can be successfully applied for the routine analysis of ibandronate sodium drug substance.
Autorenporträt
Jineetkumar Gawad is a Lecturer in Pharmacy at St. John Institute of Pharmacy & Research, Palghar. He completed his graduation from University of Pune in July 2010 and post graduation in Pharmaceutical Chemistry from North Maharashtra University in October 2012.He is author of several research papers published in national & international journals.