1*PhD Research Scholar, Pharmaceutical Quality Assurance, Sigma University, Vadodara, 390019, Gujarat, India. Email: yachita.rajwadwala@gmail.com
2School of Pharmacy, P. P. Savani University, Surat, Gujarat, India.
1Dr. Priyanka Patil, Email: drpriyankaspatil28@gmail.com
3Pharmaceutics, Laxminarayan dev College of Pharmacy, Bharuch, 392001, Gujarat, India. Email: nidhiberawala11687@gmail.com
1Dr. Mitali Dalwadi, Email: mitaliswami7@gmail.com
1Dr. Umesh Upadhyay, Email: umesh.ph@sigmauniversity.ac.in
Dapagliflozin and telmisartan combination therapy effectively manages concurrent type 2 diabetes and hypertension, necessitating advanced analytical tools for quality assurance. This study developed and validated a sustainable RP-HPLC method using a C18 column (250×4.6 mm, 5 µm), isocratic mobile phase of pH 2.5 water (0.01% OPA):acetonitrile (35:65 v/v), 1.0 mL/min flow, 10 µL injection, and 223 nm detection, achieving retention times of 4.048 min (dapagliflozin) and 6.346 min (telmisartan) with resolution 4.984. ICH Q2(R1) validation confirmed linearity (R² 0.999/0.998), accuracy (98.31-101.00%), precision (%RSD<2%), LOD/LOQ (0.61/0.53 and 1.86/1.63 µg/mL), robustness, and stability-indication via forced degradation (acid/oxidative degradations up to 18.6%). Greenness metrics scored AGREE 0.66 and BAGI 67.5, establishing this efficient, eco-conscious approach for routine pharmaceutical analysis.
Keywords: Dapagliflozin, forced degradation, greenness assessment, RP-HPLC, stability-indicating, Telmisartan
How to cite this article: Rajwadwala Y, Patil P, Chauhan N, Dalwadi M, Upadhyay U. Eco-Friendly Stability-Indicating RP-HPLC for Dapagliflozin-Telmisartan: Superior Resolution, Sensitivity & Greenness. Int J Drug Deliv Technol. 2026;16(10s): 602-609; DOI: 10.25258/ijddt.16.10s.73
Source of support: Nil.
Conflict of interest: None