气相色谱法测定盐酸贝西沙星中氯乙烷残留量

Determination of Chloroethane in Besifloxacin Hydrochloride by Gas Chromatography

在盐酸贝西沙星的合成过程中可能产生具有遗传毒性杂质氯乙烷,控制最终产品中氯乙烷的残留量是盐酸贝西沙星原料药质量控制中的一个重要指标。采用DB-624毛细管色谱柱、直接进样、程序升温的方式测定盐酸贝西沙星中氯乙烷的残留量,样品制备及进样过程均为低温操作。此方法灵敏度高、操作简便,结果准确、重现性好。

Cholroethane,a kind of genotoxic impurity,may be produced during the preparation of besifloxacin hydrochloride.Controling the residue of chloroethane in the final product is one of the important quality indexes of besifloxacin hydrochloride.In this research,a method using DB-624 capillary column,direct injection,and programmed temperature was developed for determination of the residue of chloroethane in besifloxacin hydrochloride,and sample preparation and injection process were operated at low temperature.This method is simple,sensitive,accurate and reproducible.