Simultaneous HPLC Method Development and Validation of Bilastine and Montelukast in Bulk and Formulation

Abstract

A new, simple, rapid, selective, precise and accurate reverse phase high performance liquid chromatography assay has been developed for simultaneous estimation of Bilastine, and Montelukast in tablet formulations. The separation was achieved by using Phenomenax Kinetex XB C-18 column (150 x 4.6mm, 5 .) using mobile phase Methanol: 0.1% TFA water (80:20). Injection volume was 10µl. The flow rate was 1.0mL.min-1 and the separated drugs were detected using UV detector at the wavelength of 270nm. The retention time of Bilastine and Montelukast was noted to be 1.27, and 4.86 respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent. It was successfully applied for the analysis of these drugs in marketed formulations and could be effectively used for the routine analysis of formulations containing any one of the above drugs, or a combination, without any alteration in the chromatographic conditions.