ABSTRACT

A rapid, simple, economical, accurate, and precise RP-HPLC approach for instantaneous evaluation of Dapagliflozin and Vildagliptin in the form of Combined &Bulk dosages has been validated and developed. The two drugs have also been separated by chromatography using an isocratic mode on a KinetexR C18 100A (250mm x 4.6mm x 5?m) column. The mobile phase has been supplied at a flow rate of 1ml per minute and contained KH2PO4 buffer with the pH adjusted to 3 utilizing Orthophosphoric acid and Acetonitrile in a 60:40 v/v ratio. Detection has been performed at 205nm. The retention time of Dapagliflozin & Vildagliptin has been observed to be 5.731 and 2.197 min, correspondingly. For both Dapagliflozin and Vildagliptin, the calibration curves showed a linear correlation coefficient of 0.993 and 0.99, respectively, within the concentration ranging from 10-80?g/mL & 10-80?g/mL, correspondingly. Additionally, the calibration curves have been precise, with % RSD<2.The technique could be utilized for regular quality control assessment and has been validated in accordance with ICH requirements. Keywords: Dapagliflozin, Vildagliptin, Simultaneous, RP-HPLC, Validation
Publication date: 01/07/2026

https://www.ijbpas.com/pdf/2026/July/MS_IJBPAS_2026_10325.pdf

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https://doi.org/10.31032/IJBPAS/2026/15.7.10325