Novel UHPLC DAD Method for Simultaneous determination of Vildagliptin and Metformin in Bulk and its Tablet formulation

Abstract

A robust and rapid reversed-phase UHPLC method for routine determination of vildagliptin (VILDA) and metformin (MET) was developed and validated with DAD detection (207 nm). Chromatographic analysis was carried out with isocratic separation by C18 column (150mm x 2.1mm, 5μm) using a mobile phase with a mixture of 1.36 g phosphate buffer (pH 4.2) set to phosphoric acid and acetonitrile (80:20, v/v) with 0.6mL/min flow rate. The procedure was validated as per International Conference on Harmonization (ICH) guidelines for linearity (correlation coefficient r2 = 0.999), accuracy, intermediate precision, and robustness. Accuracy was 99.79%±0.54% and 100.07 %±0.34% for VILDA and MET, respectively. For precision, the %RSD was founded to be less than 2% for three concentrations analyzed from three replicates. The proposed method was used for successful determination of VILDA and MET in a pharmaceutical preparation.