Development and Validation of RP-HPLC Method for Simultaneous Estimation of Ezetimibe and Glimepiride in Tablet Dosage Form

A simple, accurate and precise RP-HPLC method was developed and validated for simultaneous estimation of glimepiride (GLM) and ezetimibe (EZE) in tablet dosage form. Both drugs were separated on C18 Phenomenex column (250 × 4.6 mm, 5 μ) using methanol: 20mM potassium phosphate buffer (pH 3.00) (80: 20 % v/v) at flow rate of 1 mL/min. All eluents were detected at 230 nm. GLM and EZE were eluted at 5.292 and 4.183 min, respectively. The method was linear in the range of 2-10 μg/mL and 20-100 μg/mL for GLM and EZE, respectively. The developed method was further validated as per ICH Q2(R1) guidelines and applied successfully for the quantitation of tablet dosage form.