Development and validation of stability indicating assay method of vildagliptin in bulk and tablet dosage form by RP-HPLC

Abstract

A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the estimation of Vildagliptin in bulk and tablet dosage form with greater precision and accuracy. Separation was achieved on C18 column (250X4.6mm i.d.,5μm) in isocratic mode using Buffer :Acetonitrile in the ratio of 50:50(v/v) as mobile phase, pumped in to the column at flow rate of 1.0 mL min−1 and the detection of eluent from the column was carried out using variable wavelength UV detector at 220 nm. The total run time was 10 min and the column was maintained at 30⁰ C. The retention time of Vildagliptin was 5.017  min. The standard curves were linear over the concentration range of 10-60 μg mL−1 with R²  9996 and the LOD and LOQ values for  Vildagliptin were 0.025 μg mL−1 and 0.054 μg mL−1 respectively. The percentage recovery was found to be 98.11 to 101.16, the % RSD of intra-day and inter day precision was found to be 0.68 and 0.61 respectively. The percentage amount of a marketed tablet formulation of Vildagliptin was found to be 99.46 %. The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible. Hence the proposed method can be applied for the routine quality control analysis of Vildagliptin in bulk and tablet dosage forms.