Development and Validation of RP-HPLC Analytical Method for Simultaneous Estimation of Dapagliflozin and Vildagliptin in Pure and It’s Pharmaceutical Dosage Forms

The present study aimed to develop and validate a reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous quantification of dapagliflozin and vildagliptin in a tablet dosage form that was simple, sensitive, accurate, and reproducible.The chromatographic measurement was performed on a Phenomenex C8 column (150x4.6 mm, 5 um) column with an optimized mobile phase containing 0.1% Perchloric acid: ACN in ratio of 55:45.The flow rate was 0.5 ml/min,and the detecting wavelength was 214n nm.. In the concentration range Dapagliflozin and Vildagliptin were of 8 to 12μg/ml and 80 to 120μg/ml respectively showed a linear response of the suggested approach. The correlation coefficients (r2 values) for Dapagliflozin and Vildagliptinwere 0.999 and 0.999, respectively, and the retentiontimes of Dapagliflozin and Vildagliptinwas found to be 2.31 ± 0.5 min and 1.49 ± 0.5 min respectively. The developed chromatographictechnique was validated for specificity, linearity, precision, accuracy, LOD, and LOQ using ICH Q2(R1) criteria. Theanalysis results have been validated in accordance to ICH guidelines.