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Abstract

STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PIOGLITAZONE HYDROCHLORIDE AND ALOGLIPTIN BENZOATE IN PHARMACEUTICAL FORMULATION

T. Hemant Kumar* and D. Gowri Sankar

A simple, efficient, sensitive and stability indicating RP-HPLC method was developed and validated for the simultaneous estimation of Pioglitazone HCl and Alogliptin Benzoate in pharmaceutical formulation using Enable C 18G column (250 ×4.6 mm, 0.5 μm) with mobile phase consisting of acetonitrile and 0.01M Ammonium acetate (pH 4.0 adjusted with acetic acid) in the ratio of 60:40 %v/v at a flow rate of 0.8 mL/min .UV detection was carried out at 269 nm. The retention time for Pioglitazone HCl and Alogliptin Benzoate were found to be 4.611 and 4.153 min respectively. The proposed method was validated for linearity, range, accuracy, precision, robustness, LOD and LOQ. Linearity was observed over a concentration range 5-220 μg/ml for Pioglitazone HCl and 15-175 μg/ml for Alogliptin Benzoate. Pioglitazone HCl and Alogliptin Benzoate were subjected to stress conditions of degradation including acidic, alkaline, oxidative, thermal and photolysis. The developed method was found to be precise and robust for the simultaneous estimation of Pioglitazone HCl and Alogliptin Benzoate in pharmaceutical formulation. 


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