Current Advances in Analytical Methods for Quantification of Bilastine

Review Article

Abstract

Bilastine, a second-generation H1-antihistamine, has gained significant importance in treating allergic rhinoconjunctivitis and urticaria. The development of precise, accurate, and robust analytical methods for bilastine quantification is crucial for pharmaceutical quality control and research applications. Recent analytical approaches encompass UV spectrophotometry, reverse-phase high-performance liquid chromatography (RP-HPLC), and high-performance thin-layer chromatography (HPTLC). UV spectrophotometric methods have demonstrated linearity in ranges of 5-25 μg/mL with detection limits as low as 0.088 μg/mL. RP-HPLC methods utilizing various mobile phase compositions have achieved retention times between 2.167-5.126 minutes, offering superior selectivity and precision. Quality-by-Design (QbD) approaches have enhanced method robustness through systematic optimization of critical analytical parameters. Notable developments include simultaneous estimation methods for bilastine with montelukast, employing green chemistry principles and achieving detection limits in the nanogram range. Force degradation studies have revealed significant thermal sensitivity of bilastine, necessitating specific storage conditions. Modern analytical approaches have incorporated advanced statistical tools and experimental designs, resulting in methods with recovery rates exceeding 99% and relative standard deviations below 2%.