Method Development and Validation of In-Vitro Drug Release Profile For Bilastine by RP-HPLC

Abstract

Bilastine is an orally administered, second- generation antihistamine used in the symptomatic treatment of seasonal or perennial allergic rhino-conjunctivitis and urticaria. A simple, specific, linear, accurate, robust, sensitive and precise high-performance liquid chromatography method was developed for Bilastine. The column used Kromasil C18, (250 x 4.6) mm, column packed with 5μm particles, mobile phase was a mixture of buffer solution, methanol and acetonitrile in the ratio of 40:40:20 % v/v/v was pumped at a flow rate of 1 ml/min. Detector wavelength was monitored at 274 nm, and the injection volume was 20μL and run time was kept 10 min. The developed method was validated in terms of linearity, range, accuracy, precision, repeatability and specificity, robustness as per ICHQ2(R1). The method had more linearity in the concentration ranges of (10 to 150μg/mL) having with regression coefficients of 1.000. The recovery ratios were in the range of 95-105%. The precision was evaluated by studying intermediate precision and repeatability. precision was performed in a similar way another day. The %RSD values for method precision were 1.0% and intermediate precision were 0.4% respectively.