INTERNATIONAL JOURNAL OF PHARMACY & LIFE SCIENCES Development and validation of stability indicating assay method of vildagliptin in bulk and tablet dosage form by RP-HPLC

A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the estimation of Vildagliptin in bul k and tablet dosage form with greater precision and accuracy. Separation was achieved on C18 column (250X4.6mm i.d.,5 � m) in isocratic mode using Buffer :Acetonitrile in the ratio of 50:50(v/v) as mobile phase, pumped in to t he column at flow rate of 1.0 mL min1 and the dete ction of eluent from the column was carried out using variab le wavelength UV detector at 220 nm. The total run time was 10 min and the column was maintained at 30 0 C. The retention time of Vildagliptin was 5.017 mi n. The standard curves were linear over the concentration range of 10-60 � g mL1 with R 2 9996 and the LOD and LOQ values for Vildagliptin were 0.025 � g mL1 and 0.054 � g mL1 respectively. The percentage recovery was fo und to be 98.11 to 101.16, the % RSD of intra-day and inter day pre cision 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 t he proposed method can be applied for the routine q uality control analysis of Vildagliptin in bulk and tablet dosage forms.