气相色谱法测定聚乙二醇单甲醚中2-甲氧基乙醇的残留量  

Determination of 2-methoxyethanol in polyethylene glycol monomethyl ether by Gas chromatography

作　　者：高巧月 唐海磊 郭昕 刘正宇 何东升 涂家生[1,2] GAO Qiaoyue;TANG Hailei;GUO Xin;LIU Zhengyu;HE Dongsheng;TU Jiasheng(Center for Research Development and Evaluation of Pharmaceutical Excipients and Generic Drugs,School of Pharmacy,China Pharmaceutical University;NMPA Key Laboratory for Research and Evaluation of Pharmaceutical Preparations and Excipients,Nanjing 210009,China)

机构地区：[1]中国药科大学药学院药用辅料及仿创药物研发评价中心,南京210009 [2]国家药品监督管理局药物制剂及辅料研究与评价重点实验室,南京210009

出　　处：《中国药品标准》2023年第2期182-185,共4页Drug Standards of China

基　　金：国家“重大新药创制”科技重大专项资助项目(2017ZX09101001-006-002);国家药典委员会药品标准修订研究课题(2020Y041)。

摘　　要：目的:建立直接进样气相色谱法测定聚乙二醇单甲醚中2-甲氧基乙醇残留量的分析方法,为聚乙二醇单甲醚的质量控制提供参考依据。方法:采用Agilent DB-WAX(30 m×0.53 mm, 1.0μm)气相色谱柱,起始柱温40℃,保持5 min,以10℃·min^(-1)的速率升温至200℃,保持10 min。进样口温度200℃,氢火焰离子化检测器温度为250℃。样品以水溶解,液体进样。结果:2-甲氧基乙醇在0.5~2.0μg·mL^(-1)浓度范围内线性良好(r=0.995 7),平均回收率为(105.0±3.9)%(RSD=4%),检测限为0.3μg·mL^(-1),定量限为0.5μg·mL^(-1)。2-甲氧基乙醇对照品水溶液在5 d内稳定。结论:本方法操作简便、环保,具有良好的系统适用性、线性、稳定性、精密度和准确度,可用于聚乙二醇单甲醚中2-甲氧基乙醇残留量的测定。Objective:To establish a method for the determination of 2-methoxyethanol residues in polyethylene glycol monomethyl ether(PEG-MME)by direct injection gas chromatography,and to provide a reference for the quality control of polyethylene glycol monomethyl ether.Methods:Agilent DB-WAX(30 m×0.53 mm,1.0μm)column was used for gas chromatography,starting at 40℃,holding for 5 min,heating to 200℃at a rate of 10℃·min^(-1),holding for 10 min.The inlet temperature was 200℃,and the temperature of hydrogen flame ionization detector was 250℃.The sample was dissolved in water and the liquid was injected.Results:The linearity of 2-methoxyethanol was good in the range of 0.5-2.0μg·mL^(-1)(r=0.9957),the average recovery was(105.0±3.9)%(RSD=4%),the detection limit was 0.3μg·mL^(-1),the quantitative limit was 0.5μg·mL^(-1).The aqueous solution of 2-methoxyethanol was stable within 5 days.Conclusion:The method is simple and environmental friendly.It has good system applicability,linearity,stability,precision and accuracy.It can be used for the determination of 2-methoxyethanol residues in polyethylene glycol monomethyl ether.

关 键 词：2-甲氧基乙醇 气相色谱法 聚乙二醇单甲醚 

分 类 号：R921.2[医药卫生—药学]