STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF BILASTINE AND ITS IMPURITIES BY UPLC METHODAbstract
This study describes the development and validation of stability indicating UPLC method for Bilastine and its impurities, an anti-allergic drug. Bilastine was subjected to stress degradation under different conditions recommended by the International Conference on Harmonization to observe the degradation products. The successful separation of Bilastine from its synthetic impurities and degradation impurities formed under stress conditions were achieved on Acquity UPLC CSH Phenyl-hexyl (2.1 mm × 150 mm, 1.7 µ), and the gradient mode mobile phase consists of 0.05% TFA in water and 0.05% TFA in Acetonitrile. The mobile phase flow rate was 0.10 ml/min. The column temperature was maintained at 25 °C. The sample temperature was maintained at ambient and wavelength fixed at 275 nm UV-detection. It was found that the method of RPUPLC with UV-detection system for the analysis of Bilastine impurities determination and also applied in qualitative and quantitative analysis. The developed UPLC method was validated with respect to specificity, precision, linearity, ruggedness, and robustness. A validation study has been performed as per ICH guidelines.
R. Katta *, N. N. V. V. S. S. N. Murty, Ramasrinivas and G. N. Rao
Department of Inorganic and Analytical Chemistry, Andhra University, Visakhapatnam, Andhra Pradesh, India.
12 May 2019
19 September 2019
13 November 2019
01 March 2020