Abstract

The objective of this study is to develop simple, rapid and sensitive reversed-phase high performance liquid chromatography method for bilastine in tablet dosage form by quality by design approach. In reversed-phase high performance liquid chromatography method, chromatographic conditions such as mobile phase composition and flow rate were optimized with the help of Design-Expert software using central composite design. In this method, bilastine was estimated using octadecylsilane column (250×4.6 mm, 5 µm) and methanol:acetonitrile (90:10 % v/v) as mobile phase and flow rate 1 ml/ min which are optimized using Design-Expert software. Method was developed at 280 nm detection wavelength. The retention time was found to be 3.484 min. The proposed method was successfully applied to the determination of bilastine in tablet dosage form. High linearity of developed method was confirmed over concentration range of (20-120) µg/ml and correlation co-efficient is 0.9997. The percentage relative standard deviation for precision and accuracy of the method was found to be <2 %. The recovery was in the range of 98.8 %-99.7 %; limit of detection was found to be 0.1352 µg/ml and limit of quantification was found to be 0.4098 µg/ml. Bilastine was found to degrade under oxidation condition. There was no interference of excipient and degradation product in retention time, so the method was specific. Analytical parameters such as precision, accuracy, limit of detection, limit of quantification and robustness were determined according to International Conference on Harmonization guidelines.