Validated method for the simultaneous estimation of Metformin Hydrochloride and Vildagliptin by RP-HPLC in bulk and the pharmaceutical dosage form

Abstract

A RP-HPLC method was developed and validated for the simultaneous estimation of Metformin Hydrochloride and Vildagliptin in bulk and pharmaceutical dosage form. Chromatography was carried on Dionex C18 (250mm x 4.6i.d, 5µm) column with mobile phase comprising of dipotassium hydrogen phosphate(0.01M) buffer and water in the ratio 90:10 v/v. The flow rate was adjusted to 1.5ml/min with UV detection at 215nm. The retention times of Metformin Hydrochloride, Vildagliptin were found to be 2.390 min, 4.601 min respectively. The different analytical parameters such as accuracy, linearity, precision, robustness, limit of detection(LOD), limit of quantification (LOQ) were determined according to the International Conference on Harmonisation (ICH) Q2B guidelines. The detector response was linear in the range of 500-1500µg/ml, 50-150µg/ml for Metformin Hydrochloride, Vildagliptin respectively. In the linearity study, the regression equation and coefficient of correlation for Metformin Hydrochloride, Vildagliptin were found to be (y = 124986x, r2 = 1),(y = 21377x, r2 = 0.9999) respectively. The proposed method is highly sensitive, precise and accurate & hence was successfully applied for the reliable quantification of active pharmaceuticals present in the commercial formulations.