Research Information System
Pharmaceutical Chemistry Journal, vol.57, no.3, pp.460-466, 2023 (SCI-Expanded)
A fast and reliable reversed-phase high-performance liquid chromatography (HPLC) method has been developed for the simultaneous determination of vildagliptin, sitagliptin and saxagliptin in tablets. A stationary phase of Gemini C18 column (250 × 4.6 mm i.d., 5 μm) was used with a mobile phase mixture of methanol: o-phosphoric acid in gradient elution mode. The detection wavelength, flow rate and injection volume were 212 nm, 1 mL/min and 20 μL, respectively. Metformin was also screened in the same method since it is used in combination with vildagliptin and sitagliptin in tablets. The linearity ranges for vildagliptin, sitagliptin and saxagliptin determination were 5.00 – 250.0, 1.00 – 350.0 and 0.50 – 350.0 μg/mL, respectively. The limits of detection (LOD) and quantitation (LOQ) were found to be 0.86 and 2.86 μg/mL for vildagliptin, 0.27 and 0.89 μg/mL for sitagliptin, and 0.25 and 0.84 μg/mL for saxagliptin, respectively. The developed method has been applied to drugs in tablets and proved its reliability for the quality control. The application to the spiked urine samples was also successful and could be further validated for use in biological fluid analysis.