It is a faster, precise and accurate method of analysis for Empagliflozin developed by using ICH Q2(R2) guidelines with the help of RP-HPLC. This method includes Thermo scientific BDS C18 Hypersil (150cm × 4.6 mm, 5 µ) column, Mobile phase solution A: 0.1% OPA in Water (100%), Mobile phase solution B: ACN: Methanol (40:60 %V/V) at wavelength of 224 nm. The linearity, accuracy, precision, and robustness of this method were all confirmed. The range of linearity was discovered 20-60µg/mL & The correlation coefficient value was 0.999. The precision and robustness of this method was proven hence percent RSD was found less than 2%. The percentage recovery was in the range of 99.35-101.54%. LOD and LOQ were 11.75 S/N and 20.81 S/N. To evaluate the stability indicating properties degradation study by exposed with Acid (3 N HCL in a temperature range of 80°C) 3.97%, Base (3 N HCL in a temperature range of 80°C) 4.02%, A solution containing hydrogen peroxide (6% H2O2) 3.90%, Neutral for 1 hour 4.08%, UV light exposure at 294nm for 24 hours 3.02%, thermal degradation at 80oC for 1hr 3.90%..
Keywords: Development and validation of analytical method, HPLC, Empagliflozin, Stability, Forced degradation
How to cite this article: Gabhale NK, Jadhav SB, Development of Stability Indicating Assay Method and Forced Degradation Study of Empagliflozin – The Drug Acting on Metabolic Disorders By RP-HPLC Method, Int J Drug Deliv Technol. 2025;15(4): 1641-1649, DOI: 10.25258/ijddt.15.4.16