Abstract
A sensitive, accurate, precise, and robust high-performance thin-layer chromatography (HPTLC) method has been developed for the simultaneous quantification of empagliflozin, linagliptin, and metformin HCl in bulk and synthetic mixture. The method applied HPTLC aluminum plates pre-coated with silica gel 60 F254 as the stationary phase along with n-butanol:water:glacial acetic acid (6:3:1, v/v) as the mobile phase. The Rf values of empagliflozin, linagliptin, and metformin HCl were found to be 0.73, 0.52, and 0.33, respectively. Densitometric analysis was carried out in the absorbance mode at 223 nm. The method was obtained linear in the range of 0.1–0.7 μg/band for empagliflozin, 0.05–0.35 μg/band for linagliptin, and 10–70 μg/band for metformin HCl, respectively. From synthetic mixture, the percentage (%) amounts of all three drugs were found to be more than 98% by the proposed HPTLC method. The method was validated as per the International Conference on Harmonisation (ICH) guideline Q2(R1).
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