Abstract :
Background: Empagliflozin is a selective sodium-glucose co-transporter 2 (SGLT2) inhibitor used for the treatment of type 2 diabetes mellitus, offering both glycemic control and cardiovascular benefits. A reliable and validated analytical method is essential to ensure the quality and safety of pharmaceutical dosage forms containing this drug.Aims and Objective: The present study aimed to develop and validate a simple, rapid, precise, and cost-effective Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the estimation of Empagliflozin in bulk and tablet formulations.Materials and Methods: Chromatographic separation was achieved using a YMC C18 column (4.6 × 150 mm, 5 µm) with a mobile phase of methanol: water (80:20 v/v), delivered iso-cratically at a flow rate of 0.6 mL/min. Detection was carried out at 320 nm, with an injection volume of 20 ?L and a total runtime of 6 min. The method was validated according to ICH Q2(R1) guidelines.Results: Empagliflozin showed a sharp and symmetrical peak at 2.425 min. Theoretical plates (4159) and tailing factor (1.5) satisfied system suitability requirements. The method demonstrated excellent linearity (5–50 ?g/mL, R² ? 0.999), accuracy (98–102%), precision (%RSD < 2%), robustness, and high sensitivity (LOD ~0.05 ?g/mL, LOQ ~0.15?g/mL). Assay of marketed tablets revealed 98.94% purity.Conclusion: The developed RP-HPLC method is validated, economical, and highly suitable for routine quality control of empagliflozin in pharmaceutical dosage forms.
Keyword :
Empagliflozin, RP-HPLC, Method development, Validation, ICH Q2(R1), Quality control