Abstract

NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANIOUS ESTIMATION OF VILDAGLIPTIN AND METFORMIN HCL IN PHARMACEUTICAL DOSAGE FORM

G. Sreenath Reddy, N. Anjaneyulu*, R. Naga Kishore and A. Teja Sri

ABSTRACT

Objective: A New method was established for simultaneous estimation of Vildagliptin and Metformin HCl by RP-HPLC method. Methods: Chromatographic separations were carried using column AGLIENT HPLC (1100) with the E-Z Chrome Software with PDA detector with a mobile phase composition of 0.1 M Na2HPO4 and Acetonitrile have been delivered at a flow rate of 1ml/min and the detection was carried out using waters HPLC auto sampler, separation module 2695 HPLC system with PDA detector at wavelength 210nm. Results: The retention time for Vildagliptin and Metformin HCl were 6.639 and 2.653 minute respectively. The correlation coefficient values in linearity were found to be 0.999 and concentration range 50-200μg/ml for Vildagliptin and 50-200μg/ml for Metformin HCl respectively. For accuracy The total recovery was found to be 99.5 % and 99.7% for Vildagliptin and Metformin HCl. LOD and LOQ for Vildagliptin 0.0052μg/mL and 0.0158μg/ml. LOD and LOQ for Metformin HCl 0.219μg/mL and 0.665μg/ml. Conclusion: The results of study showed that the proposed RP‐HPLC method is a simple, accurate, precise, rugged, robust, fast and reproducible, which may be useful for the routine estimation of Vildagliptin and Metformin HCl in pharmaceutical dosage form.

Keywords: Vildagliptin, Metformin HCl, RP?HPLC, Simultaneous estimation.