STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF BILASTINE AND MONTELUKAST IN BULK AND TABLET DOSAGE FORM

In the present research work, a successful attempt was made for determination of Bilastine and Montelukast in Bulk and dosage form by high performance liquid chromatography. The method was developed by experimentation, based on literature survey. The simplicity, rapidity, reproducibility and economy of the proposed method completely fulfill the objective of this research work. The HPLC method was developed and validated for simultaneous estimation of Bilastine and Montelukast. The mobile phase was consisting of pH 5.5 Acetate: methanol. The linearity range of Bilastine was found to be 50-250μg/ml and Montelukast 25-125 μg/ml. The calibration curve was plotted and regression equation of Bilastine was found to be y = 9153.17x + 1658869.30 with correlation coefficient (r2) of 0.9996 and Montelukast y = 22933.18x + 2251569.30 with correlation coefficient (r2) of 0.9991. Detection was done at 225 nm and the retention time of Bilastine was found to be 4.3 min and Montelukast 11.3 min with the flow rate of 1.0 ml/min. From accuracy study % recovery of Bilastine was found in the range of 99.57- 100.07% and Montelukast is 99.667-100.45 % which is in the limits accordingly the ICH guidelines.