DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF BILASTINE IN BULK AND TABLET DOSAGE FORM

A Simple, precise, accurate, robust and selective UV Spectrophotometric method has been developed for the estimation of Bilastine from bulk and tablet formulation. This study describes the validation of an UV Spectrophotometric method for quantitative determination of Bilastine in tablets using 0.1 NaOH as solvent. The maximum absorbance was found at 260 nm. The Linearity was found to be in the range of  0.2- 1.0 µg/mL. The % RSD for Intraday precision and Interday precision studies was found to be 0.563 and 0.625 respectively. LOD and LOQ was found to be 1.05 µg/mL and 3.18 µg/mL respectively. The method was applied to marketed formulation and Bilastine content was 99.2 % with respect to labelled claim. The results suggest that this method can be employed for routine analysis of Bilastine in bulk and commercial pharmaceutical formulations.

Key words: Bilastine, UV Spectrophotometric method, Method development and method validation.