Department of Pharmaceutical Analysis, Gandhi Institute of Technology and Management, GITAM Institute of Pharmacy, Visakhapatnam, Andhra Pradesh-530045, India
Bilastine is an anti-histaminic agent used for the treatment of allergic disorders such as rhinoconjunctivitis and urticaria. A simple, new RP-HPLC method was developed and validated for the determination of purity of Bilastine in bulk and pharmaceutical dosage form. A Shimadzu ModelCBM-20A/20 Alite HPLC system equipped with PDA detector was used. The chromatographic separation was achieved using Phenomenex Gemini C18 column (150 mm × 4.60 mm i.d. 5μm particle size) with formic acid: methanol as mobile phase in the ratio of 50:50 v/v. The flow rate was maintained at 0.8mL/min. The detection was done at 282 nm. The retention time was found to be 2.167min. Bilastine showed linearity in the concentration range of 5–100 μg/mL with linear regression equation y = 15283x + 1079.7 (R2 = 0.9999). The % RSD for precession and accuracy studies were found to be < 2%.The LOD and LOQ were found to be 0.08931 and 0.27063, respectively. The proposed method was observed to be simple, economical and was validated according to the ICH guidelines for linearity, precision, accuracy and stability.
Anti-histaminic, Rhinoconjunctivitis, Urticarial, Bilastine, ICH Guidelines
