Validation and Greenness assessment of UPLC Method for bioanalysis of Bilastine in mice PK study

Bilastine, is a second-generation antihistamine drug which used in the treatment of allergic rhinoconjunctivitis and urticaria. It exerts its effect as selective histamine H1 receptor antagonist. In this study, an ultra-high-performance liquid chromatography (UPLC) method was developed to measure concentrations Bilastine mouse blood, applied measuring pharmacokinetics analyte after oral intravenous administration. The extracted by solid phase extraction method. A UPLC BEH C18 column (2.1 mm × 100 mm, 1.8 ?m particle size) for chromatographic separation gradient elution using acetonitrile-water (0.1% formic acid) mobile at flow rate 0.4 mL/min. administered mice orally 2 mg/kg intravenously 0.05 mg/kg. Blood collected various time intervals, blood samples were processed collection analyzed UPLC. intra-day inter-day accuracy 91%-103% 85%-107%, respectively, precision (RSD, %) less than 15% both measurements. matrix ranged from 95% 108%, recovery higher 70%. half-life bilastine plasma found be 7.02 ± 5.21h. has good linear relationship range 10-500 ng/mL, lower limit quantification 10 ng/mL. precision, accuracy, recovery, effect, stability meet requirements guiding principles. robust reliable fully optimized detect concentration Empower software.