RP-HPLC Method Development and Validation of Empagliflozin by using QbD Approach

Using an analytical quality by design approach, the current work aimed to establish a robust, precise, accurate, and specific HPLC method for the quantification of empagliflozin in tablet dosage form and in bulk. By using both observation and head part examination, the fundamental boundaries were accurately determined. To create mathematical models, two independent factors—flow rate and wavelength—were used. Using a C18 segment with a portable stage that contained a mobile phase composition of 0.05 M potassium dihydrogen orthophosphate buffer pH 3 and acetonitrile in a ratio of (40:60 v/v) at a flow rate of 1.0 ml/min and column temperature of 40 °C, the optimised and expected data was achieved. These ideal circumstances allowed for the baseline drug separation with good resolution and a run time of less than 2.5 minutes. A PDA indicator at 228 nm was used to finish the discovery process. ICH Q2 (R1) guidelines were followed in the validation of the optimised assay settings. Because the results were found to be robust and specific, it was evident that the Quality by Design approach could be used to successfully optimise the RP-HPLC method for routine quantification of empagliflozin HCl in bulk and tablet format.