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

A simple, precise, sensitive, and rapid reverse phase high-performance liquid chromatography method was developed and validated for simultaneous estimation of bilastine and montelukast in bulk as well as in tablet formulation according to ICH guidelines. The chromatographic phase consisted by methanol and acetonitrile (70:30) at pH 3 adjusted by 0.1% orthophosphoric acid. The flow rate was adjusted to 1 ml/min and ultraviolet detection was carried out at 260 nm. The retention time for of bilastine and montelukast were found to be 3 and 7 min, respectively. The detector was showed linear responses over the concentration range 25–150 μg/ml for bilastine and 5–30 μg/ml for montelukast a good correlation coefficient of 0.999. This proposed method is highly sensitive, precise, and accurate which reduces cost of analysis, hence recommended for routine quality analysis in laboratories