Analytical Method Development and Validation for the Simultaneous Estimation of Bilastine and Montelukast by RP-HPLC

A new, simple, rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validation of Bilastine and Montelukast in its pure form as well as in combined marketed formulation. Chromatography was carried out on a Phenomenex Luna C18 (4.6mm×250mm) 5µm particle size column using a mixture of Methanol: Phosphate Buffer (pH-4.2) (37:63% v/v) as the mobile phase at a flow rate of 1.0ml/min, thedetection was carried out at 260nm. The retention time of the Bilastine and Montelukast was found to be was 2.133, 3.692±0.02 min respectively. The method was validated according to ICH guidelines for linearity, sensitivity, accuracy, precision, specificity and robustness. The method produce linear responses in the concentration range of 20-60mg/ml of Bilastine and 10-30mg/ml of Montelukast.The inter-day and intra-day precisions were found to be within limits. 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.