Development and Validation of a RP-HPLC Method for Simultaneous Quantification of Montelukast and Fexofenadine in Pharmaceutical Formulations

Research Article

Abstract

A rapid, sensitive, and precise reversed-phase high-performance liquid chromatographic method was developed for simultaneous estimation of Montelukast and Fexofenadine in pharmaceutical formulations. The chromatographic separation was achieved on a Fortis C18 column (4.6×100µm, 2.5µm) using a mobile phase consisting of methanol and phosphate buffer (75:25 v/v, pH 4.5) at a flow rate of 0.8 mL/min. Detection was carried out at 215 nm using a UV detector. The retention times for Montelukast and Fexofenadine were 3.02 and 6.50 minutes, respectively. The method demonstrated linearity over concentration ranges of 66-396 µg/mL for Montelukast and 10-60 µg/mL for Fexofenadine with correlation coefficients exceeding 0.999. The limits of detection and quantification were 2.80 and 8.485 µg/mL for Montelukast, and 0.55 and 1.674 µg/mL for Fexofenadine, respectively. The method was validated according to ICH guidelines, showing excellent accuracy (99.41-100.81% for Montelukast and 99.59-100.61% for Fexofenadine), precision (RSD < 2%), and robustness. The validated method was successfully applied to the simultaneous determination of Montelukast and Fexofenadine in pharmaceutical formulations, demonstrating its suitability for routine quality control