Abstract
Author(s): Ghadir A Khalil1, Ismail Salama1* , Mohammed S Gomaa1 and Mohammed A Helal1
The first reversed phase high performance liquid chromatographic method for simultaneous determination of Empagliflozin, Canagliflozin, Dapagliflozin and Metformin has been developed and validated to be a simple, sensitive, rapid, specific, precise, and accurate method. Chromatographic separation was achieved on C18 column (250×4.6 mm-5µm p.s) Inertsil® ODS through isocratic elution using acetonitrile and 0.05 M potassium dihydrogen phosphate buffer PH 4 in a ratio [65:35, v/v] as a mobile phase at flow rate of 1ml/min. UV detection was operated at 212 nm and injection volum was 10 µl. Linearity range for Canagliflozin, Dapagliflozin, Empagliflozin and Metformin was 7.5-225, 5-150, 6.5-187.5 and 10-1000 µg/ml, respectively. The proposed method showed good linearity, accuracy, precision and was successfully applied for determination of the four drugs in laboratory prepared mixtures and in the seven pharmaceutical dosage forms and so it is suitable for quality control of them.