Abstract
In recent years, a lot of single-pill combinations (SPC) manufactured and are used as a promising choice in diabetes treatment. However, this trend made a serious challenge to drug analysts because of the difficulty in the analysis of two or more drugs in the presence of each other. In this study, a new validated high performance thin-layer chromatography was developed for simultaneous determination of dapagliflozin and saxagliptin in their pure form and dosage form and also successively applied as stability indicating assay of both drugs. The proposed method was based on coupling high-performance thin-layer chromatography with dual wavelength detection at 225 and 210 nm for dapagliflozin and saxagliptin, respectively. Chromatographic separations were performed on silica gel 60-F-254 aluminum plates with a mobile phase of hexane/methanol/ethyl acetate (4:2:4, v/v/v). The retention factor values were 0.6, 0.18 and a correlation coefficient of 0.9994 and 0.9995 for dapagliflozin and saxagliptin, respectively with a linear range of 50-550 ng/spot for both drugs. The optimum chromatographic conditions were applied to commercial tablet with good percent recovery values, (99.84 +/- 1.43) and (99.43 +/- 0.63) for dapagliflozin and saxagliptin, respectively. The suggested method could be applied for the studied drugs in quality control-lab as well as in their pharmacokinetic studies.