STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ALOGLIPTIN BENZOATE AND METFORMIN HYDROCHLORIDE IN TABLET DOSAGE FORM

Abstract

Objective: A new simple, accurate, precise, economic and robust stability indicating RP-HPLC method has been developed and subsequently validated for the estimation of alogliptin and metformin in bulk and pharmaceutical dosage form. Methods: The HPLC separation was carried out by using hypersil BDS, C18 (250 x 4.6 mm, 5m.) column with a mobile phase comprising phosphate buffer and acetonitrile (48:52 % v/v) pH adjusted to 4.8 with orthophosphoric acid. The flow rate of the mobile phase was 1.0 ml/min and effluent was monitored at 210 nm using PDA detector. The retention time of alogliptin and metformin was 3.78 min and 2.78 min respectively. Forced degradation studies were conducted to know the stability of the drug samples under various stress conditions like acid, base, peroxide, and photolytic degradation according to ICH guidelines. Results: The results of this study showed excellent separation of the drug samples using developed method. The percentage recoveries were found 99.91 to 101.01% for alogliptin and 99.78-100.87% for metformin which is in the limits of acceptance. The calibration curve was plotted and the method was found to be linear over a range of 3-18 µg/ml and 125–750µg/ml of alogliptin and metformin respectively and regression data for calibration curve showed good linear relationship with r 2 = 0.9990 for the both alogliptin and metformin. In the study stability section, it was observed that there is no interference of the degradation products with drug samples. Conclusion: A new stability-indicating RP-HPLC method has been developed for estimation of alogliptin and metformin in bulk and pharmaceutical dosage form. The developed method was validated, and it was found to be simple, sensitive, precise, robust and it can be used for the routine analysis of alogliptin and metformin in both bulk and pharmaceutical dosage forms.