Simultaneous Estimation and Stability Indicating Method of Vildagliptin And Dapagliflozin by RP-HPLC in Pharmaceutical Dosage Form

Abstract

Vildagliptin and Dapagliflozin drugs are used for the management of diabetes.The primary objective of the proposed research was to develop and validate analytical methods for simultaneous quantification of vildagliptin and dapagliflozin in pharmaceutical dosage form. Both the drugs were subjected to force degradation to ensure stability of pharmaceutical products. The HPLC method development was carried out on C18 column (250mm*4.6mm,5µm particle size). The chromatographic separation was achieved by isocratic mode with a mixture of Methanol: 0.01% Trifluoro acetic acid (pH-2.78) in the ratio of 95:05 % v/v as mobile phase. Flow rate was kept at 0.8 ml/min and selected wavelength for estimation was 210 nm. Stress testing with acid, alkaline, oxidative and thermal degradation was performed. The retention time was found to be 2.282 min and 4.070 min for vildagliptin and dapagliflozin, respectively. The drugs response found to be linear with correlation coefficient value was nearly 0.999 for vildagliptin and dapagliflozin with linearity range of 10 – 60 µg/ml. The recoveries from studies were found to be 99.78% and 100.17% for vildagliptin and dapagliflozin respectively. LOD and LOQ were found to be lower, hence the method proved sensitivity. Method was validated as per ICH guideline Q2(R1). Drugs had shown more degradation in oxidative condition, 10.62% and 13.52% for vildagliptin and dapagliflozin, respectively. The proposed method would be successfully applied for the stability indicating, impurity separation, qualitative and quantitative estimation of vildagliptin and dapagliflozin in pharmaceutical dosage form and in process quality control analysis.