Stability Indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Montelukast and Bilastine in Bulk and Pharmaceutical Dosage Form

https://doi.org/10.54037/WJPS.2022.100109

Abstract

A simple, Accurate, precise method was developed for the simultaneous estimation of the Bilastine and Montelukast in bulk and Tablet dosage form. Chromatogram was run through Std kromasil 250 x 4.6 mm, 5m. Mobile phase containing Buffer 0.01N Ammonium acetate: Acetonitrile taken in the ratio 70:30 was pumped through column at a flow rate of 1.0 ml/min. Buffer used in this method was Ammonium acetate buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 220.0 nm. Retention time of Bilastine and Montelukast were found to be 2.645min and 3.797 min. %RSD of the Bilastine and Montelukast were found to be 1.2% and 1.7% respectively. %Recovery was obtained as 99.74% and 99.65% for Bilastine and Montelukast respectively. LOD, LOQ values obtained from regression equations of Bilastine and Montelukast were 0.31, 0.09 and 0.94, 0.26respectively. %Assay was obtained as 100.88% and 99.54% for Bilastine and Montelukast respectively. Regression equation of Montelukast is y =25730x + 4354, y = 20467x + 3190 of Bilastine. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that it can be adopted in regular Quality control tests in Industries.