ABSTRACT:

The objective of the present work was to develop and validate a simple, selective, linear, precise, accurate and stability indicating RP-HPLC method for the simultaneous determination of Vildagliptin and Metformin from their combination drug product. The method involves the use of easily available inexpensive laboratory reagents. The proposed method is based on the separation of two drugs in the reversed phase mode using Waters C18 250 X 4.6 mm, 5µ column maintained at a temperature of 45˚C. The optimum mobile phase consisted of 0.1M phosphate buffer (pH -7): Acetonitrile (70: 30), mobile phase flow rate of 1mL min^-1 and the effluents were monitored at 263 nm. The pharmaceutical dosage form was exposed to thermal, photolytic, hydrolytic and oxidative stress conditions and the stressed samples were analyzed by the proposed method. The method was validated according to ICH guidelines. It was found to be accurate and reproducible. Linearity was obtained in the concentration range of 50-150 % for both Vildagliptin and Metformin. Mean percent recovery of triplicate samples at each level for both drugs were found in the range of 98% to 102% with RSD of less than 2.0%. The proposed method can be successfully applied in the quality control of bulk manufacturing and pharmaceutical dosage forms.