ABSTRACT:
Ertugliflozin, a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor, is widely used for managing type 2 diabetes mellitus. The current study focuses on the development and validation of a robust, accurate, and precise Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the estimation of Ertugliflozin in a laboratory-prepared tablet formulation. Chromatographic separation was achieved using a Phenomenex C18 column (250mm × 4.6mm, 5µm) with an isocratic mobile phase of acetonitrile and water in the ratio of 70:30v/v, at a flow rate of 1.0mL/min and detection wavelength of 223nm. The method was validated as per ICH Q2(R1) guidelines. Linearity was established in the range of 1.0–15.0µg/mL with a correlation coefficient (R²) of 0.99997. The method demonstrated acceptable results for system suitability, accuracy (mean recovery: 99.61%), precision (intra- and inter-day %RSD <2%), specificity, robustness, LOD (0.150µg/mL), and LOQ (0.455µg/mL). The method is suitable for routine analysis of Ertugliflozin in bulk and tablet dosage forms.
Cite this article:
Patil Hetakshi Vilas, Sunil P. Pawar, Amitkumar R. Dhankani, Manasi A. Dhankani. Analytical Method Development and Validation for Estimation of Ertugliflozin in Bulk Drug and Pharmaceutical Dosage Form by RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2025; 15(4):267-2. doi: 10.52711/2231-5675.2025.00042
Cite(Electronic):
Patil Hetakshi Vilas, Sunil P. Pawar, Amitkumar R. Dhankani, Manasi A. Dhankani. Analytical Method Development and Validation for Estimation of Ertugliflozin in Bulk Drug and Pharmaceutical Dosage Form by RP-HPLC. Asian Journal of Pharmaceutical Analysis. 2025; 15(4):267-2. doi: 10.52711/2231-5675.2025.00042 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2025-15-4-4
REFERENCES:
1. Haider K, Pathak A, Rohilla A, Haider MR, Ahmad K, Yar MS. Synthetic strategy and SAR studies of C-glucoside heteroaryls as SGLT2 inhibitor: A review. European Journal of Medicinal Chemistry. 2019; 184:111773. doi: 10.1016/j.ejmech.2019.111773.
2. Cinti F, Moffa S, Impronta F, Cefalo CMA, Sun VA, Sorice G, et al. Spotlight on ertugliflozin and its potential in the treatment of type 2 diabetes: Evidence to date. Drug Design, Development and Therapy. 2017; 11: 2905-19. doi: 10.2147/DDDT.S141849.
3. European Medicines Agency. CHMP summary of opinion Seglurome (ertugliflozin/ metformin). 2018. http://www.ema. europa.eu/. Accessed 9 Feb 2018
4. European Medicines Agency. CHMP summary of opinion: Steglujan (ertugliflozin/sitagliptin). 2018.
5. Sunkara B, Gampa TR, Markanti M, Midthapally RK. Stability indicating method development and validation for simultaneous estimation and quantification of Ertugliflozin and Metformin in bulk and tablet dosage form. Future Journal of Pharmaceutical Sciences. 2021 Dec; 7: 1-10.