DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF BILASTINE AND MONTELUKAST IN TABLET DOSAGE FORM

A simple and selective LC method is described for the determination of Bilastine and Montelukast in tablet dosage forms. Chromatographic separation was achieved on a Waters AcquityC18(50mm x2.1 mm ID) 1.8µm using mobile phase consisting of a mixture of 55 volumes of mixed Phosphate Buffer pH 3.5:  Acetonitrile (75:25) %v/v with detection of 265nm. Linearity was observed in the range 20-60 µg/ml for Bilastine (r² =0.9995)  and 10-30 µg/ml for Montelukast (r² =0.9997) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. From the above experimental results and parameters, it was concluded that, this newly developed method for the simultaneous estimation Bilastine and montelukast was found to be simple, precise, accurate and high resolution and shorter retention time makes this method more acceptable and cost effective and it can be effectively applied for routine analysis in research institutions, quality control department in meant in industries, approved testing laboratories studies in near future.

Keywords: Bilastine, Montelukast, RP‐HPLC, Simultaneous estimation.