Comparative study of HPLC-DAD and HPTLC for the simultaneous determination of a new multitarget antidiabetic ternary mixture in combined tablets

Abstract

Qternmet XR® (FDA approval, May 2019) is a multitarget anti-diabetic drug combination composed of metformin (MET), saxagliptin (SAX) and dapagliflozin (DAP). To our present knowledge, no analytical reports were found in the scientific databases for the simultaneous quantification of MET, SAX and DAP in their ternary combined tablets, moreover, no articles have attempted the simultaneous estimation of the cited drugs in any matrix using high-performance liquid chromatography with diode-array detection (HPLC–DAD) or high-performance thin-layer chromatography (HPTLC) technique. The current work represents a comparative study on two developed and validated chromatographic methods for the simultaneous determination of the ternary mixture (MET, SAX and DAP) in pure form and in combined tablet dosage form. The first method is reversed-phase HPLC using Agilent C18 column (4.6 × 250 mm, 5 μm p.s.) with a mobile phase consisting of acetonitrile and acidic aqueous phase pH 3 with a photodiode array detection at 230 nm. The second method is HPTLC in which drug solutions were applied to Merck HPTLC silica gel plates developed with a mixture of chloroform:methanol:water:acetic acid (7.4:2.6:0.5:0.01, v/v) and scanned at 224 nm. Both methods were fully validated following the ICH guidelines in terms of linearity, accuracy, precision, selectivity and robustness.