Improved Determination Method of Related Substances in Ebastine and Ebastine Tablets

OBJECTIVE To improve the method of related substances determination of ebastine and ebastine tablets. METHODS Chromatography was carried on YMC-pack ODS-A C₁₈ column (150 mm×4.6 mm, 5 μm) with the column temperature at 35 ℃, using the acetonitrile-phosphate buffer (pH 7.0) as the mobile phase at a flow rate of 1.0 mL?min^-1. the detective wavelength was set at 210 nm. RESULTS The method was effective for determination of related substance in ebastine and ebastine tablets. The detection limit and the calibration factor both of impurity C and impurity D were 0.11 μg?mL^-1 and 1.4 respectively. CONCLUSION The method proposed for determining the related substances determination of ebastine and ebastine tablets is quick, accurate and reliable.