Abstract

METHOD DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR THE ESTIMATION OF BILASTINE IN PHARMACEUTICAL DOSAGE FORM

V. Amarendra Chowdary*, Anusha Kota and Syed Muneer

ABSTRACT

In the present investigation simple, sensitive and economical new analytical method was developed for the Bilastine by RP-HPLC method. The developed and validated RP-HPLC method was found to be more economical due to the short analytical run time. Optimum results were attained with methanol: Acetonitrile (60:40) mobile phase. The peaks were symmetric and sufficiently resolved. Bilastine was found to shown appreciable absorbance at 254nm when determined spectrophotometrically and hence it was selected as the detection wavelength. System suitability was assessed by injecting 100μg/ml of Bilastine standard concentration. Concentration range of 10-250μg/ml for Bilastine was found to be linear with correlation coefficients 0.999 for Bilastine. The proposed method was found to be precise and reproducible with %RSD of less than 2. The percent recovery was found to be 97.02% to 101.52% which indicates that the method was accurate. The limits of detection for Bilastine was found to be 0.0249μg/ml and the limits of quantitation were found 0.0757μg/ml. Hence, the developed RP-HPLC method can be adopted for the routine analysis of Bilastine in bulk and pharmaceutical dosage form in quality control laboratories.

Keywords: RP-HPLC, Bilastine, Method Validation.