STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF GLIMEPIRIDE AND EZETIMIBE IN BULK AND TABLET DOSAGE FORM

A simple, rapid, sensitive, precise, accurate and economic isocratic stability indicating RP-HPLC chromatographic method was developed and validated for the simultaneous estimation of Glimepiride and Ezetimibe in bulk and tablet dosage form. The method was developed through a Hypersil ODS C₁₈ (150mm x 4.6 mm, 5m) column, mobile phase comprised of phosphate in water as buffer P^H adjusted to 4.8 with tri ethylamine, acetonitrile in proportion ratio 30:70v/v and at the flow rate of 1 ml/min. GLM and EZE were eluted at acceptable retention times of 3.328 and 2.322 minutes respectively with good resolution by monitoring UV detection at 237 nm. Calibration plots were linear in the concentration range of 2.5-15 µg/ml for GLM and 25-150 μg/ml for EZE with correlation coefficient(r²) 0.999 and 0.999 respectively. The total run time is 6 min. The studies were carried out by conducting deliberate degradation of the sample with exposure to stress conditions like acidic (1M HCl), alkaline (1M NaOH), 105⁰C heat, oxidizing agents (H₂O₂) and water. This method was validated and met the regulatory requirements for specificity, Linearity, LOD, LOQ, Precision, accuracy and stability for the determination of glimepiride and ezetimibe in bulk and tablet dosage form by RP-HPLC.