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中国药物评价 ›› 2020, Vol. 37 ›› Issue (1): 36-37.

• 评价技术与方法 • 上一篇    下一篇

离子色谱法测定地塞米松磷酸钠注射液中亚硫酸氢钠的含量

戴震   

  1. 南京市食品药品监督检验院
  • 收稿日期:2020-01-13 修回日期:2020-02-11 出版日期:2020-02-28 发布日期:2020-03-30

Determination of Sodium Bisulfite in Dexamethasone Sodium Phosphate Injection by Ion Chromatography

zhen zhendai   

  • Received:2020-01-13 Revised:2020-02-11 Online:2020-02-28 Published:2020-03-30
  • Contact: zhen zhendai E-mail:373763896@qq.com

摘要: 目的:利用离子色谱(IC)法测定地塞米松磷酸钠注射液中亚硫酸氢钠的含量。方法:色谱柱DionexIonpac AS11-HC(Thermo),流动相:淋洗液自动发生器,20 mMKOH,柱温30 ℃,流速1.0 mL·min-1,进样体积25 μL,采集时间30 min,检测方式为抑制电导检测。结果:亚硫酸氢钠在5~200 μg·mL-1范围内,线性关系良好,r2=0.099 98。检测限为7.5 ng。加样回收率为101.0%,RSD为0.6%。结论:本方法准确度高,专属性强,重现性好,操作简单,适用于亚硫酸氢钠含量的测定。

关键词: 亚硫酸氢钠, 离子色谱法, 亚硫酸根, 含量测定

Abstract: Objective:The content of SdiumBsulfite in DxamethasoneSdiumPosphate injection was determined by IC method. Methods:Chromatographic column DionexIonpac AS11-HC (Thermo), Mobile phase: automatic eluent generator, 20 mMKOH, column temperature 30 ℃, flow rate 1.0 mL·min-1, injectionvolume 25 μL, collection time 30 min, detection method for inhibiting conductivity detection. Results:The linear relationship of sodium bisulfite was good in the range of 5~200 μg·mL-1, r2=0.099 98. The detection limit was 7.5 ng. The recovery was 101.0% and RSD was 0.6%. Conclusion: The method is accurate, specific, reproducible and easy to operate. It is suitable for the determination of sodium bisulfite.

Key words: Sodium bisulfite, Ion chromatography, Sulfite, Content determination

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