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

Place of Study: Department of Pharmacy, University College of Technology, Osmania University, Hyderabad, Telangana.

Aim: The present study is describing about the development of a new RP-HPLC method for the simultaneous estimation of Bilastine and Montelukast in Active Pharmaceutical Ingredient (AI) and commercial formulations.

Methodology: In the present investigation, an Inertsil ODS C18 column dimensions of 250 mm length x 4.6 Internal diameter x 5-micron particle size has been chosen. Phosphate buffer and acetonitrile were opted as isocratic mobile phase at a ratio of 30:70, with a flow rate of 1 ml/min. The pH of the developed buffer was maintained at 4.6 and the temperature was set at room temperature. The wavelength of Bilastine and Montelukast was observed at 260 nm. For both Bilastine and Montelukast the retention time has been observed at 2.319 and 4.299 minute correspondingly. The percentage purity of both the drugs was found to be 100.6 % and 100.3 % correspondingly. The developed method satisfied all the system suitability parameters for Bilastine and Montelukast and the observed values for theoretical plates were found to be 1.3 and 1.4 respectively, tailing factor were found to be 5117.5 and 3877.8 respectively with a resolution of 9.0.

Results: Finally, the method was validated by parameters such as precision, accuracy, robustness and ruggedness. The linearity and range were from 1-5µg and 100-500 µg concentrations series, the correlation coefficient for both the drugs was noted to be 0.999 while the mean percentage recovery was observed at 100.1 percent & 100.4 percent. The % RSD for repeatability was found to be 0.31 and 0.38. The % RSD of intermediate precision was found to be 0.12 & 0.15 correspondingly. The LOD values were found as 2.94, 3.03 and for the LOQ values were found as 9.87, 10.1.

Conclusion: The developed method which was validated was observed to be novel, accurate, simple, robust, precise, repeatable for the present study with a suitable RP-HPLC technique to concurrently determine Bilastine and Montelukast present in the commercial formulation. This developed method is useful on daily basis due to their accurate results, reproducibility, robustness for the estimation of samples in routine quality control departments.