气相色谱法测定盐酸氯丙嗪注射液中5种抗氧化剂

Determination of 5 antioxidants in chlorpromazine hydrochloride injection by gas chromatography

建立气相色谱法测定盐酸氯丙嗪注射液中5种抗氧化剂。采用乙酸乙酯作为提取溶剂,HP-1701毛细管色谱柱分离,分流比为10∶1,用氢火焰离子化检测器(FID)检测,色谱峰面积外标法定量。5种抗氧化剂能实现完全分离,其质量分数在0~100μg/mL范围内与色谱峰面积有良好的线性关系,相关系数均大于0.999,检出限为2.0~4.0mg/kg,定量限为5.0~9.0 mg/kg。样品加标回收率为89.36%~95.92%,测定结果的相对标准偏差均小于8%(n=6)。该方法可满足盐酸氯丙嗪注射液中5种抗氧化剂含量的检测。

A gas chromatography method was established to determine five antioxidants in chlorpromazine hydrochloride injection.Ethyl acetate was used as the extraction solvent,separated by HP-1701 capillary chromatography column with a split ratio of 10∶1,detected by hydrogen flame ionization detector(FID),and quantified by chromatographic peak area external standard method.Five antioxidants could achieve complete separation,and their mass fractions had good linear relationships with chromatographic peak areas in the range of 0-100μg/mL,and correlation coefficients were more than 0.999.The detection limits were 2.0-4.0 mg/kg,and the quantification limits were 5.0-9.0 mg/kg.The recoveries of sample spiking were 89.36%-95.92%,the relative standard deviations of the measurement results were less than 8%(n=6).This method can meet the detection of 5 antioxidant contents in chlorpromazine hydrochloride injection.