盐酸左西替利嗪胶囊中光学异构体杂质的毛细管电泳法测定

Determination of the enantiomeric impurity in Levocetirizine Hydrochloride Capsules by HPCE

目的建立高效毛细管电泳分析(HPCE)法,提高盐酸左西替利嗪胶囊的质量控制水平。方法以磺丁基-β-环糊精(SBE-β-CD)和0.03g·mL^-1α-环糊精(α-CD)为手性选择剂;25mmol·L-1磷酸二氢钾溶液作为运行缓冲液(pH值为2.5);分离电压为-15kV;检测波长为205nm。结果盐酸右西替利嗪质量浓度在1.25~20.00μg·mL^-1范围内(r=0.9991),光学异构体杂质的定量限为0.0005mg·mL^-1,平均回收率为101.8%(n=9)。结论该方法不需要使用有机溶剂,环境友好,实验成本较低,专属性好、结果准确,适用于盐酸左西替利嗪胶囊中光学异构体杂质的控制。

Objective To establish a robust and accurate high performance capillary electrophoresis(HPCE)method for the determination of enantiomeric impurity in Levocetirizine Hydrochloride Capsules to improve the quality control standards.Methods Electrophoretic separation was performed with 25 mmol·L-1 potassium dihydrogen phosphate(pH 2.5)including 0.03 g·mL^-1 sulfobutyl ether-β-cyclodextrin(SBE-β-CD)and 0.03 g·mL^-1α-cyclodextrin(α-CD)as running buffer,under-15 kV separate voltage and detection wavelength of 205 nm.Results The linear range of dextrocetirizine hydrochloride was 1.25-20.00μg·mL-1(r=0.999 1);the limit of quantitation(LOQ)for enantionmeric impurity was 0.000 5 mg·mL^-1;the average recoveries were 101.8%(n=9).Conclusion The proposed method does not require organic solvents,therefore is friendly for environment and low-cost.The method is proved to be robust,accurate,and can be successfully applied for the determination of enantiomeric impurity in Levocetirizine Hydrochloride Capsules.