离子色谱法测定硫辛酸注射液中的乙二胺
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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 PacCG17(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 TheIC 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 m L·min-1,thedetector was conductivity detector( with a suppressor CERS 500,4 mm) and the injection volume was 10 μL. RESULTS Thelinear range of the ethylenediamine was from 33. 48 μg·m L-1 to 133. 92 μg·m L-1(r = 0. 9988). The average recovery was98. 65% with the RSD of 0. 98%. CONCLUSION The method is simple,accurate and suitable for the quantitative control ofThioctic acid injection,as well as the assay of ethylenediamine in similar products.
OBJECTIVE To detect ethylenediamine in Thioctic acid injection by Ion chromatography( IC). METHOD TheIC 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 m L·min-1,thedetector was conductivity detector( with a suppressor CERS 500,4 mm) and the injection volume was 10 μL. RESULTS Thelinear range of the ethylenediamine was from 33. 48 μg·m L-1 to 133. 92 μg·m L-1(r = 0. 9988). The average recovery was98. 65% with the RSD of 0. 98%. CONCLUSION The method is simple,accurate and suitable for the quantitative control ofThioctic acid injection,as well as the assay of ethylenediamine in similar products.
引文
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[6]陈赞民,陈颖江.气相色谱法测定氨茶碱及其制剂中乙二胺的含量[J].药物分析杂志,2012,32(9):1673-1676.
[7]刘文,马平,李平,等.气相色谱内标法测定乙二胺、哌嗪及三乙烯二胺含量[J].应用化工,2014,43(3):554-556.
[2]杜斌,蔡维维,杨志勇,等.硫辛酸对多发性脑梗死大鼠抗氧化能力的影响[J].华西药学杂志,2015,30(3):310-311.
[3]杜斌,陈炜,陈俊良,等.硫辛酸对百草枯中毒大鼠胸腺的保护作用[J].华西药学杂志,2016,31(4):359-360.
[4]杜洪洋.硫辛酸注射液质量研究[J].黑龙江医药,2013,26(2):218-221.
[5]刘绪贵.硫辛酸注射液处方工艺优化及质量标准提高[D].济南:山东大学硕士学位论文,2017.
[6]陈赞民,陈颖江.气相色谱法测定氨茶碱及其制剂中乙二胺的含量[J].药物分析杂志,2012,32(9):1673-1676.
[7]刘文,马平,李平,等.气相色谱内标法测定乙二胺、哌嗪及三乙烯二胺含量[J].应用化工,2014,43(3):554-556.