Development and Validation of Stability Indicating Assay Method of Bilastine by Ultra-Fast Liquid Chromatography (UFLC)

Post approval by Drugs Controller General of India, Bilastine had been recently introduced in India as novel non-sedating second-generation Hl-antihistamines (SGAHs). It has been approved for commercialization to adults as well as adolescents (≥12yrs) in most European countries since 2010. Urticarial and allergic rhino- conjunctivitis symptomatic treatment, 20mg daily dose has been recommended. A review of the literature revealed that there are just a few Ultra-Violet spectroscopy, HPTLC, HPLC, and fluorimetric procedures available. Specificity, accuracy, Limit of Quantification (LOQ), linearity, Limit of Detection (LOD), precision, and robustness of method have all been validated to fulfill guidelines of International Council for Harmonization (ICH). With a lower limit of detection of and quantification were found to be 0.17µg/ml and 0.51µg/ml, calibration curve appeared linear through concentration range of 10-100µg/ml. A novel, sensitive, and selective Ultra-Fast Liquid Chromatography (UFLC) technique has been developed for determining the amount of bilastine in pharmaceutical dosage forms and bulk. Chromatographic separation had been conducted on C18 column (4.6mm×150mm, 3µm spherical particles) with "Acetonitrile: Water: Methanol" in a 30:30:40 ratio at 1.0mL/min then "monitored at 215nm. Run time was 20 min.