RP-HPLC Based Stability Indicating Assay of Evogliptin and Metformin: Development and Validation of the Analytical Method

Abstract

Background: Several new fixed dose combinations have been recently approved by the Food and Drug Administration for treatment of disease conditions. All these combinations require specific, accurate and precise analytical methods for estimation for simultaneous estimation.

Methods: A new RP-HPLC method was developed for the stability indication of evogliptin and metformin in tablets and it was validated as per ICH guidelines. The chromatogram for was found to be satisfactory on symmetry C-18 (4.6×150mm, 5µ Kromasil column) using phosphate buffer (pH 4.5) and acetonitrile in the ratio of 30:70 v/v at a flow rate of 0.8 ml/min.

Results: The retention time of evogliptin and metformin were found to be 7.03 min and 9.50 min respectively. The system suitability parameters proved that the proposed method was found to be suitable for stability indication of evogliptin and metformin. Tailing factor for the peak was found to be 1.003 and 1.258. The method was found to be linear in the range of 10-50µg/ml for both the drugs. The precision of the method was good and the recovery of drugs is well within the acceptance limits of 80-120%. The LOD and LOQ was found to be 0.003 µg/ml, 0.12 µg/ml and for evogliptin and 0.09 µg/ml and 0.03 µg/ml for metformin.

Conclusion: A simple, accurate and precise method tor routine analysis of the combination of evogliptin and metformin was developed and was applicable for the stability analysis of the combination.