RP-HPLC Method Development and Validation for the Simultaneous Estimation of Bilastine and Montelukast Sodium in Tablet Dosage Form

Abstract

A new, simple, specific, accurate, precise and reproducible analytical method has been developed and validated for the simultaneous estimation of Bilastine and Montelukast sodium in Tablet Dosage Form. Bilastine is a selective histamine H1 receptor and montelukast is a leukotriene antagonist receptor. The aim of experiment was to develop and validate RP-HPLC method for the estimation of Bilastine and Montelukast sodium in tablet dosage from. Ofloxacin was used as an internal standard. The HPLC system used for analysis was JASCO, PU 2075plus, UV 2080 plus with a column Qualisil 5 BDS-C18 (250 mm x 4.6 m, 5 µm). Acetonitrile: potassium dihydrogen phosphate buffer (pH adjusted to 6.2 with TEA) in the ratio of 38:82 was used as mobile phase. The optimized conditions were: flow rate (1.2 ml/min), wavelength (254 nm), injection volume (20 µl), working time was 10 minutes. 

The retention times of Bilastine, Ofloxacin, and Montelukast sodium were found to be 3.017min, 4.367min, and 7.342min respectively. % Assay was found to be 101.13% for Bilastine and 99.67% for Montelukast sodium. The linearity range of Bilastine and Montelukast sodium were found to be 2-14 µg/ml and 4-28 µg/ml with a correlation coefficient (r²) of 0.9994 and 0.9998 respectively. % Recovery was obtained as 99.91%-100.56% and 99.45%-100.38% for Bilastine and Montelukast sodium respectively. LOD and LOQ was found to be 0.107μg/ml and 0.325μg/ml for Bilastine and 0.412μg/ml and 1.248μg/ml for Montelukast sodium. The analytical method was validated as per ICH guidelines. The method was robust and rugged as observed from insignificant variation in the results of analysis by changes in flow rate and mobile phase composition separately and analysis being performed by different analysts.