DEVELOPMENT AND VALIDATION OF REVERSE PHASE HPLC DISSOLUTION METHOD FOR DETERMINATION OF IBANDRONATE SODIUM IN TABLET DOSAGE FORM
Jineetkumar B. Gawad*1, Pritam S. Jain2, Atul A. Shirkhedkar2, Sanjay J. Surana2
1St. John Institute of Pharmacy and Research, Palghar (E), M.S India.
2R. C. Patel Institute of Pharmaceutical Education and Research, Shirpur (M.S.) India.
ABSTRACT
A simple, accurate and sensitive liquid chromatographic method has been developed for the determination of ibandronate sodium drug substance in tablet dosage form. The separation was achieved on Hypersil BDS C18 (250mm X 4.6mm), 5μm column. 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 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.
Keywords: Reverse Phase HPLC, Ibandronate sodium, Stability indicating, Validation.
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