GC法测定右雷佐生中有机溶剂的残留量  

Determination of Residual Organic Solvents in Dexrazoxane by Capillary GC

作　　者：彭飞城 杨跃龙 李昌亮 李帅 刘雁鸣 兰文 易必新 PENG Fei-cheng;YANG Yue-long;LI Chang-liang;LI Shuai;LIU Yan-ming;LAN Wen;YI Bi-xin(Hunan Institute for Drug Control and Testing,Hunan Changsha 410001;NMPA Key Laboratory for Pharmaceutical Excipients Engineering Technology Research,Hunan Changsha 410001;Hunan Drug Inspection Centerl,Hunan Changsha 410001;Huaihua Inspection and Testing Center,Hunan Huaihua 418000,China)

机构地区：[1]湖南省药品检验检测研究院,湖南长沙410001 [2]国家药品监督管理局药用辅料工程技术研究重点实验室,湖南长沙410001 [3]湖南省药品审核查验中心,湖南长沙410001 [4]怀化市检验检测中心,湖南怀化418000

出　　处：《广州化工》2024年第2期181-183,共3页GuangZhou Chemical Industry

基　　金：湖南省2024年度部门联合基金项目(No:2024JJ8177)。

摘　　要：建立右雷佐生原料药中3种有机溶剂的残留量的测定方法。采用毛细管气相色谱法,FID检测器,氮气为载气,DB-FFAP色谱柱(60 m×0.53 mm×1μm),程序升温,进样口温度为220℃,FID检测器温度为280℃,载气流速7.5 mL/min,对甲醇、乙醇、乙酸乙酯的残留量进行检测。甲醇、乙醇、乙酸乙酯的检测限分别为0.31、0.60、0.44μg/mL;各成分在考察的浓度范围内有良好的线性关系;平均回收率为101.6%~101.8%,RSD为1.02%(n=6)。该法适用于右雷佐生原料药中这3种有机溶剂残留量的同时测定,专属性强,灵敏度高,结果可靠。To determine three residual organic solvents in active pharmaceutical ingredient(API)of dexrazoxane by capillary Gas chromatography(GC),DB-FFAP column(60 m×0.53 mm×1.0μm)was used with FID as detector and nitrogen as carrier gas.The inlet temperature was 200℃and the FID detector temperature was 250℃,the flow rate of carrier gas was 7.5 mL/min.The detection limit of methanol,ethanol,acetoacetate was 0.31,0.60,0.44μg·mL^(-1),respectively.Good linearity was obtained in the experimental concentration range.The average recovery rate was ranged from 101.6%to 101.8%with RSD of 1.02%(n=6).The method was specific,sensitive,simple and credible,which could be used for determination of three residual solvents in esomeprazole at the same time.

关 键 词：气相色谱法 右雷佐生 有机溶剂残留 

分 类 号：R917[医药卫生—药物分析学]