壬苯醇醚中残留溶剂的定量研究  

Quantitative investigation on residual solvents in Nonoxinol-9

作　　者：张伟[1] 张慧[1] 陈度宇 梁成罡[1] ZHANG Wei;ZHANG Hui;CHEN Duyu;LIANG Chenggang(Division of Hormone,National Institutes for Food and Drug Control,NMPAKey Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院激素室,国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629

出　　处：《中国药品标准》2022年第6期664-668,共5页Drug Standards of China

摘　　要：目的:利用气相色谱法建立壬苯醇醚中甲醛、环氧乙烷以及1,4-二氧六环的定量检查方法。方法:采用DB-624(0.53 mm×30 m,3.00μm)毛细管色谱柱(固定相为6%氰丙基苯基-94%二甲基聚硅氧烷),以氮气为载气,FID检测器,采用程序升温,顶空进样,标准曲线法计算各组分含量。结果:该方法的系统适用性、专属性、线性、精密度和准确度均符合规定。结论:本方法简便、灵敏、准确,可对壬苯醇醚中的甲醛、环氧乙烷以及1,4-二氧六环进行质控。Objective:To establish a method for the determination of formaldehyde,ethylene oxide and 1,4-dioxane in Nonoxinol-9 by headspace gas chromatography.Methods:A DB-624 capillary column(0.53 mm×30 m,1.00μm)was used,the carrier gas was nitrogen and FID was as detector.The contents of each component were tested via temperature-programmed,split-flow direct injection,and calculated by standard curve method.Results:The gas chromatography validation results for system suitability,specificity,linearity,precision and recovery all met the requirement.Conclusions:This method is simple,sensitive,accurate and suitable for the quality control of formaldehyde,ethylene oxide and 1,4-dioxane in Nonoxinol-9.

关 键 词：壬苯醇醚 气相色谱法 毛细管色谱柱 顶空进样 残留溶剂 定量研究 

分 类 号：R921.2[医药卫生—药学]