离子色谱法测定硫辛酸注射液中的乙二胺  

Determination of ethylenediamine in Thioctic acid injection by Ion chromatograpy

作　　者：傅萍 刘峰 谢华 FU Ping;LIU Feng;XIE Hua(Sichuan Food and Drug Inspection and Testing Institute,Chengdu,Sichuan,611731 P.R.China)

机构地区：[1]四川省食品药品检验检测院,四川成都611731

出　　处：《华西药学杂志》2019年第1期86-88,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的采用离子色谱法测定硫辛酸注射液中乙二胺的含量。方法采用RFICTM Ion PacCG17(50 mm×4 mm)、CS17(250 mm×4 mm)阳离子交换色谱柱,以15 mmol·L-1甲基磺酸-乙腈(90∶10)为流动相,流速0. 8 m L·min-1,检测器为电导检测器(带抑制器CERS 500,4 mm),进样体积10μL。结果乙二胺的线性范围为33. 48～133. 92μg·m L-1(r=0. 9988),平均回收率为98. 65%,RSD=0. 98%。结论所用方法简便、准确,可用于该制剂中乙二胺的控制,同时,还可用于同类产品中乙二胺的测定。OBJECTIVE To detect ethylenediamine in Thioctic acid injection by Ion chromatography(IC).METHOD The IC method was performed on a cation exchange column RFICTM Ion Pac?CG17 (50 mm×4 mm)and CS17 (250 mm×4 mm) with the mobile phase of 15 mmol·L^-1 methanesulfonic acid -acetonitrile (90 :10).The flow rate was 0.8 mL·min^-1 ,the detector was conductivity detector(with a suppressor CERS 500,4mm)and the injection volume was 10 μL.RESULTS The linear range of the ethylenediamine was from 33.48 μg·mL^-1 to 133.92 μg·mL^-1 (r =0.9988 ).The average recovery was 98.65% with the RSD of 0.98%.CONCLUSION The method is simple,accurate and suitable for the quantitative control of Thioctic acid injection,as well as the assay of ethylenediamine in similar products.

关 键 词：离子色谱法 阳离子交换柱 电导检测器 硫辛酸注射液 乙二胺 含量测定 定量控制 质量研究 

分 类 号：R917[医药卫生—药物分析学]