蔡鹏,蔡鹏,黄伟,袁华峰.离子色谱法测定酚磺乙胺注射液的含量[J].中国药品标准,2017,18(4):294-297 |
离子色谱法测定酚磺乙胺注射液的含量 |
Determination of Etamsylate Injection by Ion ChromatographyCai Peng,Huang Wei,Huang Xiaozhen,Yuan Huafeng(Taizhou Institute for Drug and Food Control,Taizhou 225300) |
投稿时间:2017-05-04 修订日期:2017-08-01 |
DOI: |
中文关键词: 酚磺乙胺 离子色谱 含量测定 |
英文关键词: etamsylate ion chromatography assay |
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中文摘要: |
目的:建立测定酚磺乙胺注射液中酚磺乙胺含量的方法。方法:采用离子色谱法,色谱柱为CS17A(4 mm×250 mm),保护柱为CG17A(4 mm×50 mm);检测器采用带DIONEX CSRS? 300 4-mm抑制器的电导检测器;流动相为5mmol.L-1 甲烷磺酸溶液,流量为1 mL.min-1;柱温30℃。结果:酚磺乙胺在0.05225~1.045mg.mL-1范围内,色谱峰面积与其浓度呈良好线性关系(Y = 0.023X +0.585,r=0.999 9),回收率为101.6%,RSD为0.82%。结论:本方法简便、快速、可准确地对酚磺乙胺注射液中酚磺乙胺含量进行测定。 |
英文摘要: |
Objective: To establish an assay method of etamsylate in etamsylate injection by ion chromatography. Methods: The assay was performed on CS17A column( 4 mm × 250 mm) and CG17A guard column ( 4 mm×50 mm) with cationic suppressor and electrolytic conductivity detector. The mobile phase was 5 mmol.L- 1 methanesulfonic acid solution with 1 mL.min- 1 flow rate. The temperature of column was 30℃. Results: Within 0.05225 -1.045 mg.mL-1 etamsylate had a good linearity ( Y = 0. 023X +0.585,r=0.999 9) , the average recovery was 101.6% with RSD of 0.82%. Conclusion: The method is proved to be simple,rapid and sensitive for evaluating the quality of etamsylate in etamsylate injection. |
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