The objective of present research work to develop a novel validated stability indicating RP-UPLC method for the simultaneous estimation of Alogliptin and Pioglitazone in bulk and tablet dosage form. The mobile phase was optimized using phosphate buffer (pH 3) and methanol in the ratio of 45:55%v/v. UV detector wavelength monitored at 280 nm. The linearity was obtained in the range of 6.25-37.5 µg/ml for Alogliptin and 15-90µg/ml for Pioglitazone. Chromatographic separation was achieved on by using waters BEH C18 (2.1x50mm, 1.7µ) and the flow rate was maintained at 0.3 ml/min. The injection volume was 2µl. The run time was found to be 3 min. The retention time was found to be 0.403 min for Alogliptin and 0.529 min for Pioglitazone. The developed method was validated statically according to ICH guidelines. The proposed method was more precise, accurate, reproducible, robust and all the validation results were found to be better than the existed RP-HPLC methods, it can be employed for routine quality control analysis of pharmaceutical formulations.
Key words: Alogliptin, Pioglitazone, BEH C18, RP-UPLC, phosphate buffer
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