Comparative high-performance liquid chromatographic and high-performance thin-layer chromatographic study for the simultaneous determination of dapagliflozin and metformin hydrochloride in bulk and pharmaceutical formulation

Abstract

The discovery of potent antidiabetic drugs is of necessity owing to the rapid prevalence of diabetes worldwide. The investigation of a new separation method for the simultaneous determination of combined antidiabetic drugs is thus an essential issue to cover the usual demands of simple analytical methods for the routine analysis. Therefore, herein, simple and fast chromatographic methods were established for synchronized determination of metformin (MET) and dapagliflozin (DAP), a mixture approved recently by the Food and Drug Administration (FDA) for diabetes therapy. In high-performance liquid chromatography (HPLC), a Water-pak C18 column was used as the stationary phase with an isocratic mobile phase composed of 10 mM NaH2PO4 (pH 3.5 adjusted using ortho-phosphoric acid)‒acetonitrile (65:35, v/v) containing 0.1% trimethylamine at a flow rate of 1.2 mL min−1 and a wavelength detector set at 225 nm. In high-performance thin-layer chromatography (HPTLC), separation was achieved on pre-coated silica gel 60 ...