用纤维素衍生物手性固定相HPLC法拆分盐酸西替利嗪对映体

Enantiomorph of cetirizine hydrochloride by HPLC method with cellulose derivative chiral stationary phase

目的:建立一种用手性固定相HPLC法拆分盐酸西替利嗪对映体的方法。方法:选用CHIRALCEL OD-H色谱柱(250mm×4.6mm,5μm),考察了流动相组成比例、酸性添加剂比例及流速对盐酸西替利嗪对映体拆分效果的影响。结果:确定了下列拆分条件:以正己烷∶乙醇∶三氟乙酸(80∶20∶0.05,V/V/V)为流动相,流速为0.8 ml/min,柱温为25℃,检测波长为230nm,盐酸西替利嗪对映体能够得到良好的拆分,右旋体和左旋体的保留时间分别为9.6 min和12.0min,分离度为1.64。结论:该法操作简单,可用于盐酸西替利嗪对映体的分离和质量控制。

Objective：To establish a chiral stationary phase HPLC method for the enantiomorph of cetirizine.Methods：CHIRALCEL OD-H column（250 mm×4.6 mm,5μm）was used.Effects of the component proportion of mobile phase,proportion of acid additive and flow rate on enantiomorph were investigated.Results：The optimized chromatographic conditions were as follows：the mobile phase was hexane∶ethanol∶ trifluoroacetic acid（80∶20∶0.05,V/V）,with a flow rate of 0.8 ml/min and the detection wavelength of 230 nm.The column temperature was set at 25 ℃.The cetirizine enantiomers could be well separated with a resolution factor of 1.64 and the resolution time for d-and l-cetirizine were 9.6 min and 12.0 min,respectively.Conclusion：This method is simple to operate and could be used for the separation and quality control of cetirizine enantiomers.