Design of Experiment Approach for Method Development and Validation of Bilastine in Pure and Pharmaceutical Dosage form using RP-UFLC

Abstract

Background: Bilastine is a H1 receptor antagonist, used in the treatment of allergic urticaria, seasonal rhinitis, etc. Few journals have reported the analytical related work on bilastine drugs. Objective: The objective of the work is to develop a simple, precise, rapid, and reproducible method using design of experiments (DOE) and check the optimized conditions when run on UFLC would give the best method or not. Results: The DOE software was used to select optimized conditions with minimal runs. The central composite design was the best fit, with two variables that include flow rate and column temperature. A total of 13 runs gave optimum conditions of 1.2 mL/min flow rate, column temperature of 40°C and mobile phasemethanol: buffer (pH 6.0) in the ratio of 70:30 in the binary mode using the Shimadzu C18 column on an HPLC instrument. The retention time of bilastine was found to be 5.126min, the number of theoretical plates and asymmetric factor being within the limit. The proposed method was validated as per the ICH Q2R1 guidelines. The linearity was found to be in the range of 1.25 µg/mL-10 µg/mL. The correlation coefficient was found to be within the limits i.e., R2=0.999. The accuracy of the current method was being performed using the %recovery at three stages 50%, 100%, and 150% and was found to be 99.5126%, 100.2765% and 99.6714% respectively. The LOD and LOQ of bilastine was found to be 0.292 µg/mL and 0.974 µg/mL. Conclusion: The DOE software reduced the number of trials, saving both time and solvent consumption. This method can be conveniently used with confidence for regular assay, which is a simple, precise, rapid, and reproducible one for the estimation of bilastine in pure and pharmaceutical tablet dosage form using UFLC.