DEVELOPMENT AND STANDARDIZATION OF STABILITY INDICATING UV-SPECTROPHOTOMETRIC METHOD FOR ASSESSMENT OF BILASTINE IN BULK AND PHARMACEUTICAL DOSAGE FORMULATION

The objective of the present work is to develop and standardize the UV-Spectrophotometric method for the assessment of Bilastine in bulk and pharmaceutical dosage forms.  On account of not much work being reported on the drug Bilastine and also it is a new second-generation anti-histamine molecule. Hence it is necessary in this context to relook into the older methods and further research for new methods to decide on the efficacy, cost, and selectivity of the method. The λ_max of bilastine was found at 282.5 nm. Beer’s law was obeyed in the concentration range of 10-50 mg/ml. The limit of detection and limit of quantification were found to2.94 mg/ml and 8.92 mg/ml respectively. Recovery of Bilastine in tablet formulation was observed in the range of 96-105%. All the precision, repeatability, and reproducibility studies were performed, and the % RSD was found to be less than 2%. The % degradation of Bilastine by acidic, basic, oxidation, thermal and photolytic degradation was found to be 6.04, 6.97, 10.68, 9.05, 6.5%, respectively. The method for the drug Bilastine was found to be precise, specific, reproducible & economical, and can be used for routine analysis of Bilastine in bulk and marketed dosage form.