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Determination of Three Gliptins in Tablets by Reversed Phase Liquid Chromatography with an Application of Spiked Urine Samples

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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.

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Acknowledgements

Authors would like to thank Seda Kahramaner, Nusret Kara and Elif Terlemez for their valuable support. The ethical approval number: B.08.06. YOK. 2. I. U. E. 50. 0. 05. 00/02, Date: 5th of March, 2014, Committee Name: Local Ethics Committee of Istanbul University, Institute of Cardiology.

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Authors and Affiliations

  1. Department of Analytical Chemistry, Faculty of Pharmacy, Istanbul University, Beyazit, Istanbul, Turkey

    Sena Caglar Andac

  2. Department of Analytical Chemistry, Faculty of Pharmacy, YeniYuzyil University, Istanbul, Turkey

    Elif Ozdemir

  3. Department of Medical Pharmacology, Faculty of Medicine, Yeditepe University, Istanbul, Turkey

    Cenk A. Andac

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  1. Sena Caglar Andac
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Correspondence to Sena Caglar Andac.

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Andac, S.C., Ozdemir, E. & Andac, C.A. Determination of Three Gliptins in Tablets by Reversed Phase Liquid Chromatography with an Application of Spiked Urine Samples. Pharm Chem J 57, 460–466 (2023). https://doi.org/10.1007/s11094-023-02905-1

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