Development and Validation of RP-HPLC Method for Simultaneous Estimation of Vildagliptin and Metformin

A RP-HPLC method was developed and validated for the simultaneous estimation of Vildagliptin (VIDA) and Metformin Hydrochloride (MET) in bulk and pharmaceutical dosage form. Chromatography was carried on Warers HPLC, Lichrocart C18 column (250 x 4.60 x 5μm) with mobile phase comprising of 0.05 M KH₂PO₄ : Acetonitrile (70:30 v/v pH 3.5 with Ortho Phosphoric Acid). The flow rate was adjusted to 1.0 ml/min with UV detection at 215 nm. The retention times of VIDA and MET were found to be 6.64 and 5.18 minutes respectively. The different analytical parameters such as accuracy, linearity, precision, robustness, ruggedness were determined according to the ICH Q2B guidelines. The detector response was linear in the range of 5-25 μg/ml, 10-50 μg/ml for VIDA and MET respectively. In the linearity study, the regression equation and correlation of coefficient for VIDA and MET were found to be (y = 1014x + 54.43, R2 = 0.999) and (y = 307.8x + 146.0, R2 = 0.999) respectively. The proposed method is highly sensitive, precise and accurate. Hence this method developed successfully and applied for the routine quantification of active pharmaceuticals present in the commercial formulations.