DEVALOPMENT AND VALIDATION OF STABILITY INDICATING QUANTITATIVE ESTIMATION OF DAPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

A new, simple, fast, selective, precise and accurate RP-HPLC method was developed and validated for the estimation of Dapagliflozin from bulk and marketed formulations. The proposed method was developed by HPLC Waters ODS C18 column, 5m, 25cmx4.6mm i.d, Separation Module with UV detector connected to D Elite 2000 software with an injection volume of 20 μl was injected and eluted with a mobile phase composition of Buffer (Potassium hydrogen orthophosphate & pH adjusted to 4.2 with orthophosphoric acid) and Methanol in a ratio of 65:35. Mobile phase is pumped at a flow rate of 1.0 ml/min and detected by UV detector at 225nm. Ambient column temperature has maintained. The retention time of Dapagliflozin was found to be 2.93 min. Linearity was observed in the concentration range of 20-100 μg/ml for Dapagliflozin with correlation coefficient 0.999. The proposed method was found to be precise and reproducible with %RSD of 0.42 for dapagliflozin. Percent recovery obtained in the range of 99.25 to 101.16% w/w for dapagliflozin. The LOD & LOQ were found to be 0.003 & 0.009 µg/ml respectively.The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The results of the stress studies indicated the specificity of the method that has been developed. Dapagliflozin was stable in both oxidation & acidic stress conditions. The result shows the developed method is yet another suitable method for assay & stability which can help in the analysis of Dapagliflozin in different formulations. Key words: Dapagliflozin, RP-HPLC and Stability