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25μL,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5~200μg·mL-1范围内,线性关系良好,r2=0.09998.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.
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 25μL,collection time 30 min,detection method for inhibiting conductivity detection.Results:The linear relationship of sodium bisulfite was good in the range of 5~200μg·mL-1,r 2=0.09998.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.
作者
戴震
DAI Zhen(Nanjing Food and Drug Supervision and Inspection Institute,Jiangsu Nanjing,China)
出处
《中国药物评价》
2020年第1期36-37,共2页
Chinese Journal of Drug Evaluation
关键词
亚硫酸氢钠
离子色谱法
亚硫酸根
含量测定
Sodium bisulfite
Ion chromatography
Sulfite
Content determination