摘要
目的采用衍生化GC-MS法测定罗红霉素中潜在遗传毒性杂质2-甲氧基乙氧基甲基氯(MEM)的含量。方法采用异丙醇做溶剂并作为衍生化试剂。衍生物采用HP-5MS UI(30 m×0.25 mm,0.25μm)色谱柱分离,选择离子监测模式检测。结果MEM衍生物在2.412~19.30 ng·mL^(-1)与峰面积的线性关系良好;检测限为0.6μg·g^(-1);回收率为70.1%~90.4%,RSD为9.30%(n=9)。3批罗红霉素样品均未检出MEM衍生物。结论所用方法灵敏度高、专属性强,可用于罗红霉素中潜在遗传毒性杂质MEM的检测。
OBJECTIVE To determine the 2-methoxyethoxymethyl chloride(MEM)by derivatization GC-MS method,a potentially genotoxic impurity in Roxithromycin.METHODS Isopropyl alcohol was used as both solvent and derivatization reagent.The derivative were separated by HP-5MS UI(30 m×0.25 mm,0.25μm),and determined by selected ion monitoring mode.RESULTS A good linear relationship was obtained between the peak areas and the concentrations of derivative of MEM chloride in the range of 2.412-19.30 ng·mL^(-1).The recoveries were 70.1%-90.4%,and the RSD was 9.30%(n=9).Limit of detection was 0.6μg·g^(-1).MEM derivative was not detected in three batches of Roxithromycin samples.CONCLUSION The method is sensitive and specific,which can be used for the quality control of MEM in Roxithromycin.
作者
邓鸣
曾庆花
梁秋霞
彭斌
卢日刚
朱健萍
DENG Ming;ZENG Qinghua;LIANG Qiuxia;PENG Bin;LU Rigang;ZHU Jianping(Guangxi Institute for Drug Control,Nanning,Guangxi,530021 P.R.China;Guilin Pharmaceutical Co.Ltd.,Guilin,Guangxi,541004 P.R.China)
出处
《华西药学杂志》
CAS
CSCD
北大核心
2024年第6期710-712,共3页
West China Journal of Pharmaceutical Sciences
基金
广西科技重大专项(桂科AA22096025)。
作者简介
邓鸣,女,副主任药师,从事药品质量控制与标准的研究工作。Email:34482178@qq.com;通信作者:朱健萍,Email:22701650@qq.com。
