Determination of Related Impurities in Ebastine Tablets by HPLC

Determination of related impurities in ebastine tablets by high performance liquid chromatography. Phenyl bonded silica gel xtimate phenylhexyl chromatographic column (4.6 mm×250 mm, 5 μm) was used for separation, with phosphate buffer solution-acetonitrile (60+40) mixed solution was used as the mobile phase A, and the phosphate buffer solution-acetonitrile (70+30) mixed solution was used as the mobile phase B at the flow rate of 1.0 mL·min^-1. As shown by the results, linear relationships between values of peak area and mass concentration of the 4 impurities were found in the definite ranges, with detection limits (3S/N) in the range of 0.16-0.33 mg·L^-1. Test for recovery by standard addition method was made on the base of ebastine tablet sample, giving results in the range of 96.0%-104%, and RSDs (n=6) ranged from 0.83% to 4.2%.