GC-FID法同时测定8种儿童用药品中二甘醇和乙二醇的含量  

Simultaneous Determination of Diethylene Glycol and Ethylene Glycol in Eight Pediatric Drugs by GC-FID Method

作　　者：王晓锋 黄嘉琪 许凯 赵霞[1] 杨锐[1] WANG Xiaofeng;HUANG Jiaqi;XU Kai;ZHAO Xia;YANG Rui(National Key Lab.for Quality Control of Pharmaceutical Excipients,National Institutes for Food and Drug Control,Beijing 100050;China Pharmaceutical University,Nanjing 210009)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局药用辅料质量研究与评价重点实验室,北京100050 [2]中国药科大学,江苏南京210009

出　　处：《中国医药工业杂志》2025年第3期403-407,共5页Chinese Journal of Pharmaceuticals

摘　　要：建立了气相色谱-氢火焰离子化检测器法同时测定8种共18批儿童用药品中二甘醇(1)和乙二醇(2)的含量。采用DB-624色谱柱(0.32 mm×30 m×1.8μm),程序升温,进样口温度为180℃,检测器温度为250℃。结果显示,方法专属性好,1和2的重复性RSD均小于3%。1和2均在50~800μg/mL内线性关系良好。18批儿童药物制剂的1和2回收率在90%~101%,RSD为1.2%~3.1%。1和2的检测限分别为4.8、5.0μg/mL,定量限分别为13.8、14.4μg/mL,为市售儿童用药品中高风险杂质成分1和2的含量检测提供了参考。A gas chromatography with hydrogen flame ionization detector(GC-FID)was established to simultaneously determine the contents of diethylene glycol(1)and ethylene glycol(2)in 18 batches of 8 types of pediatric drugs.The DB-624 chromatography column(0.32 mm×30 m×1.8μm)was used,and the temperature was programmed to increase.The inlet temperature was 180℃,and the detector temperature was 250℃.The results showed that the method had good specificity,with a repeatability RSDs of less than 3%for both 1 and 2.And it was linear for 1 and 2 in the range of 50-800μg/mL.In 18 batches of pediatric drug preparations,the recovery rates of 1 and 2 were between 90%and 101%,with RSDs ranging from 1.2%to 3.1%.The detection limits of 1 and 2 were 4.8 and 5.0μg/mL,respectively,and the quantification limits were 13.8 and 14.4μg/mL,respectively,which provided a reference for the detection of 1 and 2 as the high-risk impurities in commercially available pediatric drugs.

关 键 词：儿童用药 二甘醇 乙二醇 气相色谱-氢火焰离子化检测器法 

分 类 号：R917[医药卫生—药物分析学] R985[医药卫生—药学]