RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF ALOGLIPTIN BULK AND TABLET DOSAGE FORM

This present study reports, a simple, specific, accurate and validated Reverse Phase-Rapid Resolution Liquid Chromatography for identification of Alogliptin. The method employed Inertsil Extend C18 (250 × 4.6 mm, packed with 5 µm) and mobile phase Water and Acetonitrile (70:30), at flow rate of 1.0 ml/min and UV-detection at 252 nm and it was detected with run time (RT) of 2.766 mins. No other co-eluting, interfering peak from excipients, impurities, or degradation products due to variable stress conditions was found, and method is specific for the identification of the Alogliptin. The method was validated in terms of linearity, precision, accuracy. Present work also describes the development and validation of HPLC method for the identification of Alogliptin. The method employed same chromatographic condition as above and validated in terms of linearity, accuracy, precision and system suitability. Keywords: RP-HPLC, Alogliptin, Method Development and Validation.