1Department of Pharmaceutical Quality Assurance, Parul Institute of Pharmacy, P.O. Limda, Tal: Waghodia, Vadodara, PIN code- 391760, Gujarat, India
*Corresponding Author: Ms. Puja Bhavsar, Department of Pharmaceutical Quality Assurance, Parul Institute of Pharmacy, P.O. Limda, Tal: Waghodia, Vadodara, PIN code- 391760, Gujarat, India. Email: Poojabhavsar676@gmail.com
Received: 16th Dec, 2025; Revised: 8th Feb 2026; Accepted: 12th Feb, 2026; Available Online: 28th Feb, 2026
The purpose of the present study was to develop a simple, precise and accurate HPLC method for simultaneous estimation of Dapagliflozin and Vildagliptin in their pharmaceutical dosage form. Symmetry C18 (250 x 4.6 mm, 5 µm) was used as stationary phase and Acetonitrile: phosphate buffer (60:40 v/v; pH 3.5 by OPA) was used as mobile phase and detection of wavelength was found at 218 nm. The retention time of Vildagliptin and Dapagliflozin was found to be 2.5 min and 5.5 min. The method was linear in the concentration in the range of 100-300 µg/ml for Vildagliptin and 10-30 µg/ml for Dapagliflozin with correlation coefficient (r²) 0.9989 for Vildagliptin and 0.9958 for Dapagliflozin. Accuracy of Vildagliptin and Dapagliflozin was found with in acceptance criteria 98%-102%. The proposed method was validated as per ICH Q2 (R1) guideline.
Keywords: Vildagliptin, Dapagliflozin, HPLC, ICH Q2(R1), Validation
How to cite this article: Bhavsar P*, Bera K, Patel Z, Singh S, Patel S, Patel J, Patel A, Development and validation of HPLC method for simultaneous estimation of Dapagliflozin and Vildagliptin in their pharmaceutical dosage form. Int J Drug Deliv Technol. 2026; 16(2): 397-404; DOI: 10.25258/ijddt.16.2.44
Source of support: Nil.
Conflict of interest: None