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  

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

作　　者：戴震 DAI Zhen(Nanjing Food and Drug Supervision and Inspection Institute,Jiangsu Nanjing,China)

机构地区：[1]南京市食品药品监督检验院,江苏南京210009

出　　处：《中国药物评价》2020年第1期36-37,共2页Chinese Journal of Drug Evaluation

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.

关 键 词：亚硫酸氢钠 离子色谱法 亚硫酸根 含量测定 

分 类 号：R927[医药卫生—药学]