QUALITY BY DESIGN (QBD) APPROACH TO DEVELOP STABILITY-INDICATING RP-HPLC METHOD DEVELOPMENT FOR BILASTINE AND MONTELUKAST

Background and Objectives: As per requisition of current regulatory requirements, the simple, rapid and sensitive method by 3³ factorial QbD approach was established and validated for Bilastine (BST) and Montelukast (MNT) by RP-HPLC. Method: A simple RP-HPLC method has been developed and validated with different parameters such as linearity, precision, repeatability, LOD, LOQ, accuracy as per International Conference for Harmonisation guidelines (Q2R1). Statistical data analysis was done for data obtained from different aliquots Runs on Agilent Tech. Gradient System with Autoinjector, UV (DAD) & Gradient Detector. Results: Equipped with Reverse Phase (Agilent) C₁₈ column (4.6mm x 100mm; 5µm), a 20µl injection loop and UV730D Absorbance detector at 226nm wavelength and running chemstation 10.1 software and drugs along with degradants were separated via acetonitrile: water 0.1% OPA (45:55), of pH 3 as mobile phase setting flow rate 0.8 ml/min at ambient temperature. The developed method was found linear over the concentration range of 10-50 /ml for BST and 5-25 μg/ml for MNT, while detection and quantitation limit were found to be 0.4825 μg/ml and 0.2144μg/ml as LOD and 2.2653 μg/ml and 0.07 μg/ml respectively for Bilastine and Montelukast. Conclusion: There are no interfering peaks underperformed degradation conditions. Therefore, a sensitive, robust, accurate, and stable indicating method was developed with high degree of practical utility.