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

A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Montelukast and Bilastine, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Zorbax C18 (4.6 x 150mm, 5µm) column using a mixture of Methanol: Phosphate Buffer pH 3.9 (55:45v/v) as the mobile phase at a flow rate of 1.0ml/min, the detection was carried out at 255nm. The retention time of the Montelukast   and Bilastine was 2.061, 2.462 ±0.02min respectively. The method produce linear responses in the concentration range of 1-5µg/ml of Montelukast and 100-500µg/ml of Bilastine. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of bulk and pharmaceutical formulations.

Keywords:  Montelukast, Bilastine, RP-HPLC, validation.