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

Abstract

A new RP-HPLC method was developed for the estimation of bilastine and montelukast in tablets and it was validated as per ICH guidelines. The chromatogram for was found to be satisfactory on symmetry C-18 (4.6×150mm, 5µ Thermosil column) using phosphate buffer (pH 4.5) and acetonitrile in the ratio of 30:70 v/v at a flow rate of 0.8 ml/min. The retention time of montelukast and bilastine were found to be 7.03 min and 9.50 min respectively. The system suitability parameters proved that the proposed method is suitable for simultaneous estimation of bilastine and montelukast. Tailing factor for the peak was found to be 1.003 and 1.258 for montelukast and bilastine respectively and the theoretical plates for separation were found to be 3409 and 7365 respectively montelukast and bilastine. The method was found to be linear in the range of 10-50µg/ml for both the drugs. The precision of the method was good and the recovery of drugs is well within the acceptance limits of 80-120%. The LOD was found to be 0.003 µg/ml for montelukast and 0.09 µg/ml for bilastine while the LOQ ws found to be 0.012 µg/ml for montelukast and 0.3 µg/ml for bilastine. KEYWORDS: Montelukast, Bilastine, RP-HPLC, simultaneous estimation, validation, analytical method.