Abstract
A novel, sensitive, suitable and robust strong-cation-exchange RP-HPLC technique was designed and evaluated towards the purpose of identifying dapagliflozin in tablet formulation. The separation was performed with HPLC system containing UV- detector with Openlab EZchrome software and kromasil C18, and methanol and water (75:25 % v/v) as mobile phase flowing at 1.0 ml/min. using UV detector, the detection was performed at 223 nm. Dapagliflozin was eluted with retention time of 5.27 min. The results of analysis have been evaluated with respect to stability, specificity, linearity, accuracy, precision (repeatability and intermediate precision) and robustness. A simple, specific, rapid and reproducible technique has been designed in order to analyse dapagliflozin in tablet formulation.
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