ABSTRACT

A new simple, specific, precise and accurate RP-HPLC method has been developed for determination of Vildagliptin and Metformin Hydrochloride in pharmaceutical dosage form. The mobile phase used in this study was composed of Acetonitrile: 0.05% TFAA in water at the ratio of 15:85 v/v, with isocratic elution using Phenomenex C18 column (250 mm X 4.6 mm i.e., Volume 20?L. Injection volume was 20?L and flow rate was 1.0 mL/min. The column was maintained at ambient temperature and the eluent was monitored at 210nm. The retention time for Metformin was 2.02 and for Vildagliptin 3.37 with run time of 7 min. Metformin hydrochloride and Vildagliptin Standard and Sample solution was found stable for 24 hours Hence both solutions can be used up to 24 Hrs. The validation method was developed as per ICH Q2R1guidelines. The developed technique was validated for accuracy, precision, linearity, robustness, LOD, LOQ, system suitability, specificity studies and result were analyzed according to the ICH Q2R1 guideline. Keywords: Vildagliptin, Metformin Hydrochloride, method development, validation, RP- HPLC, Pharmaceutical dosage form
Publication date: 01/05/2026

https://www.ijbpas.com/pdf/2026/May/MS_IJBPAS_2026_10209.pdf

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https://doi.org/10.31032/IJBPAS/2026/15.5.10209