6^th Asia-Pacific Pharma Congress

Biography

Biography: Jineet Kumar Gawad

Abstract

Simple, accurate, precise and sensitive liquid chromatographic methods have been developed for the determination of ibandronate sodium drug substance in bulk and tablet dosage form. The separation was achieved on Hypersil BDS C18 column (250mm X 4.6mm), 5μm particle diameter. The mobile phase consisted of Buffer: ACN (95:05) v/v; flow rate 1.0 ml min−1 at ambient temperature. The analytes were monitored by PDA detector. The average recoveries for ibandronate were in the range of 99.0–102.0%. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolytic, thermal and humidity degradation. Considerable degradation was achieved under thermal condition. Mass balance was demonstrated in all stress conditions. The method was validated for specificity, precision, linearity, solution stability and accuracy. Another method is developed for determination of impurities (phosphate and phosphite) of ibandronate sodium. The separation was achieved on AllsepTM anion column 150mm×4.6mm, 7μm particle diameter. The mobile phase consisted of 0.2% (v/v) aqueous formic acid with pH 3.1 and ACN 95:5% (v/v); flow rate 0.5 ml min−1 at ambient temperature. The analytes were monitored by refractive index detector. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolytic, thermal and humidity degradation. Considerable degradation was achieved only under oxidative condition. Mass balance was demonstrated in all stress conditions. The method was validated for specificity, precision, linearity, solution stability and accuracy. The average recoveries for impurities and ibandronate were in the range of 99.0–102.0% and both methods can be successfully applied for the routine analysis of ibandronate sodium.