Development and validation of new analytical method for estimation of form dapagliflozin and metformin HCL drugs pharmaceutical dosage forms

Abstract

The estimation of Dapagliflozin and Metformin was accomplished with C18 column (4.6×250 mm and 5 µm particle size) with DAD detector. The mobile phase consists of Methanol: Water 74:35%v/v of pH-3 adjusted with 0.05% OPA at flow rate of 1mL/min. The detection wavelength was 233 nm, respectively. In the developed method, the retention time of Dapagliflozin and Metformin HCL was found to be 5.099 min and 2.165 min. The reverse phase high performance liquid chromatography method produces linear response that was found in the range of 100-500 µg/mL. The limit of detection and limit of quantification for Dapagliflozin were found to be 0.06 µg/mL and 0.1855 µg/mL, respectively and for Metformin 6.09 µg/mL and 18.45 µg/mL, respectively. Calculated information acquired for both the preliminaries roughly coordinates with the information given by design expert programming which shows the genuineness of the chromatographic condition. The developed method was validated according to the ICH guidelines. The linearity, precision, range, and robustness were within the limits as specified by the ICH guidelines. Hence, the method was found to be simple, accurate, precise, economic, and reproducible.