Development and validation of analytical method for estimation of bilastine in bulk and pharmaceutical (tablet) dosage form

Background: The present work describe a simple, linear, precise, robust, accurate and selective HPLC method for estimation of Bilastine in bulk and tablet dosage form. Bilastine is a second generation antihistamine medication. Generally it is used for treatment of allergic rhinoconjunctivitis and urticaria (hives). Methanol: Acetonitrile: Phosphoric Acid Buffer pH 2.1 in proportion of (21:33:46) was used as mobile phase with flow rate 1.0 ml/min. The column used for the method development is 250 x 4.6 mm x 5 mu m dimension. Result: In the range of 5-25 mu g/ml the linearity of Bilastine shows a correlation coefficient of 0.9981. Conclusion: The method was validated as per ICH guidelines for linearity, precision, accuracy, robustness.