Development of a Green Capillary Electrophoresis Method for Determining and Quality Control of Dapagliflozin: An Oral Hypoglycemic Agent.

A green method by capillary electrophoresis (CE) is described for the first time for the determination of dapagliflozin (DAPA), an oral hypoglycemic drug approved for the treatment of Type 2 diabetes mellitus. The effects of different analytical conditions were evaluated, including the concentration and pH of the background electrolyte (BGE), sample injection time, applied voltage, as well as capillary temperature. The method was validated by establishing the linearity, intra- and interday precisions (relative standard deviation, RSD%), accuracy, and robustness. The analytical procedure was linear in the range of 50-175 µg mL-1 (R2 > 0.999), with the limit of detection (LOD) and limit of quantitation (LOQ) of 6.2 and 18.8 µg mL-1, respectively. Precision had an intraday RSD of 2.55% and an interday RSD of 2.52%. The average recovery rates for the pharmaceutical samples ranged from 101.22% to 104.63%, with an RSD of 0.88%. Additionally, the CE method was compared to a high-performance liquid chromatography (HPLC) method for quantifying DAPA, and their green profiles were assessed by the Analytical Greenness Metric (AGREE), confirming the eco-friendliness of the CE technique. The methodology is suitable for determining DAPA in tablets; CE provides a greener alternative due to low-cost analysis using fewer organic solvents and minimizing waste generation.