A simple and efficient stability-indicating method has been developed and validated for the simultaneous estimation of vildagliptin, metformin hydrochloride and remogliflozin etabonate in bulk and was applied on marketed formulations. KH2PO4 buffer (10 mM): Acetonitrile (70:30% v/v) at pH 5 was used as a mobile phase. Detection of drug peaks was at 215 nm by UV detector. The method was found to be linear in the concentration range of 2.5 to 7.5, 25 to 75 and 5 to 15 μg/mL for vildagliptin, metformin hydrochloride and remogliflozin etabonate, respectively. The limit of detection (LoD) and quantitation (LoQ) were found to be 0.137 and 0.415 μg/mL for vildagliptin, 3.737 and 11.326 μg/mL for metformin hydrochloride and 0.348 and 1.055 μg/mL for remogliflozin etabonate. Hydrolysis by HCl, NaOH, hydrogen peroxide, UV light and temperature were performed on a formulation which proves that the proposed method was specific
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CS et al. (2024) studied this question.
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