Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for the Simultaneous Estimation of Dapagliflozin and Sitagliptin in Tablet
Abstract
This study developed and validated a robust UV spectrophotometric and RP-HPLC method for the simultaneous estimation of dapagliflozin and sitagliptin in tablets, adhering to ICH guidelines. UV analysis identified λmax at 223 nm (dapagliflozin) and 267 nm (sitagliptin). The concentration ranges employed to assess linearity for dapagliflozin, and sitagliptin were 5-25 µg/ml, and 25-125 µg/ml, achieving linearity with R² > 0.999 and accurate recovery rates in range of 98–102%. Assay was found to be 106.4 for dapagliflozin and for 102.8 sitagliptin. RP-HPLC employed a Phenomenex Luna LC C18 (150mmX4.6mm,5µm) column with acetonitrile: methanol: water (25:35:40) as the mobile phase, at a flow rate of 1 ml/min. Detection was carried out at 215 nm retention time of dapagliflozin and sitagliptin was found to be 7.1 and 4.9 min. The method demonstrated linearity for dapagliflozin (4–20 µg/ml) and sitagliptin (20–100 µg/ml) with R² > 0.999, and %RSD < 2% for precision. The % recovery of spiked sample was 100% (dapagliflozin) and 98.5% (sitagliptin). Assay results for a marketed formulation revealed 90% and 104.3% of labelled amounts for dapagliflozin and sitagliptin, respectively, ensuring compliance with pharmaceutical standards. Both methods were precise, accurate, and robust, suitable for routine quality.
Keywords
References
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Details
Primary Language
English
Subjects
Pharmaceutical Analytical Chemistry
Journal Section
Research Article
Authors
Publication Date
May 11, 2026
Submission Date
June 13, 2025
Acceptance Date
September 24, 2025
Published in Issue
Year 2026 Volume: 30 Number: 3
APA
Karjkhede, V., Gajeli, G., Mhamane, S., & Birajdar, D. (2026). Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for the Simultaneous Estimation of Dapagliflozin and Sitagliptin in Tablet. Journal of Research in Pharmacy, 30(3), 909-920. https://doi.org/10.12991/jrespharm.1718804
AMA
1.Karjkhede V, Gajeli G, Mhamane S, Birajdar D. Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for the Simultaneous Estimation of Dapagliflozin and Sitagliptin in Tablet. J. Res. Pharm. 2026;30(3):909-920. doi:10.12991/jrespharm.1718804
Chicago
Karjkhede, Vaishnavi, Ganesh Gajeli, Supriya Mhamane, and Divya Birajdar. 2026. “Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for the Simultaneous Estimation of Dapagliflozin and Sitagliptin in Tablet”. Journal of Research in Pharmacy 30 (3): 909-20. https://doi.org/10.12991/jrespharm.1718804.
EndNote
Karjkhede V, Gajeli G, Mhamane S, Birajdar D (May 1, 2026) Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for the Simultaneous Estimation of Dapagliflozin and Sitagliptin in Tablet. Journal of Research in Pharmacy 30 3 909–920.
IEEE
[1]V. Karjkhede, G. Gajeli, S. Mhamane, and D. Birajdar, “Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for the Simultaneous Estimation of Dapagliflozin and Sitagliptin in Tablet”, J. Res. Pharm., vol. 30, no. 3, pp. 909–920, May 2026, doi: 10.12991/jrespharm.1718804.
ISNAD
Karjkhede, Vaishnavi - Gajeli, Ganesh - Mhamane, Supriya - Birajdar, Divya. “Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for the Simultaneous Estimation of Dapagliflozin and Sitagliptin in Tablet”. Journal of Research in Pharmacy 30/3 (May 1, 2026): 909-920. https://doi.org/10.12991/jrespharm.1718804.
JAMA
1.Karjkhede V, Gajeli G, Mhamane S, Birajdar D. Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for the Simultaneous Estimation of Dapagliflozin and Sitagliptin in Tablet. J. Res. Pharm. 2026;30:909–920.
MLA
Karjkhede, Vaishnavi, et al. “Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for the Simultaneous Estimation of Dapagliflozin and Sitagliptin in Tablet”. Journal of Research in Pharmacy, vol. 30, no. 3, May 2026, pp. 909-20, doi:10.12991/jrespharm.1718804.
Vancouver
1.Vaishnavi Karjkhede, Ganesh Gajeli, Supriya Mhamane, Divya Birajdar. Development and Validation of UV-Spectrophotometric and RP-HPLC Methods for the Simultaneous Estimation of Dapagliflozin and Sitagliptin in Tablet. J. Res. Pharm. 2026 May 1;30(3):909-20. doi:10.12991/jrespharm.1718804