Analytical Method Development and Validation for Estimation of Ertugliflozin in Bulk Drug and Pharmaceutical Dosage Form by RP-HPLC

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.