Estimation and Validation of Bilastine in Pharmaceutical Dosage Form and in Bulk Drug by Spectrophotometric Method

Abstract

A simple, sensitive, accurate, rapid and economical Spectrophotometric method was developed for estimation and validation of Bilastine in pure drug and tablet dosage form. The absorbance was measured at 226.2nm using Methanol as solvent system. It obeyed Beer’s law at the concentration range of 2-12µg/ml with coefficient of correlation (r2) of 0.9993. Limit of detection (LOD) was found to be 1.224µg/ml and Limit of quantitation (LOQ) was found to be 4.088µg/ml. The proposed analytical method was validated according to ICH guidelines, yielded good results concerning range, linearity, precision, accuracy, robustness and ruggedness.