New RP-HPLC Method for Bilastine Estimation in Pharmaceutical and Bulk Dose Form

Abstract

Bilastine is a frequently prescribed H1-antihistaminic that is authorized for the safe and efficient symptomatic management of allergic conditions, such as urticaria and rhino conjunctivitis. For the quick and precise measurement of bilastine, an Agilent Technologies LC compact 1120 module, a Shimadzu UV-1700 detector with a 20µl injection volume, and an xBridge TM C18 column were used in developing the validated Reverse Phase HPLC method. The procedure used a mobile phase made up of a 60:40, v/v% combination of methanol, 10 mM potassium dihydrogen phosphate at pH 3.5. By using the working standard solution, 10 µg/ml, satisfactory linearity shown over 5–30 µg/ml concentration range (correlation coefficient: 0.9924). Detection was done at 275 nm with a five-minute reaction time and the flow rate was maintained at 1.0 ml/min. The precision, accuracy, linearity, and robustness of the approach were confirmed by statistical validation in compliance with ICH criteria. This implies that the method for figuring out the tablet formulations is suitable.

DOI: https://doi.org/10.52783/jchr.v15.i2.7707