离子色谱法测定聚乙二醇6000中有机酸和无机阴离子  

Determination of organic acids and inorganic anions in polyethylene glycol 6000 by ion chromatography

作　　者：谢莹莹 赵勇 肖菁 石蓉 尹林高 张悦 郑金凤 XIE Ying-ying;ZHAO Yong;XIAO Jing;SHI Rong;YIN Lin-gao;ZHANG Yue;ZHENG Jin-feng(Hunan Institute for Drug Control,Changsha 410001;Hunan Drug Inspection Center,Changsha 410001;Key Laboratory for Pharmaceutical Excipients Engineering Technology,NMPA,Changsha 410001)

机构地区：[1]湖南省药品检验检测研究院,长沙410001 [2]湖南省药品审核查验中心,长沙410001 [3]国家药品监督管理局药用辅料工程技术研究重点试验室,长沙410001

出　　处：《中南药学》2023年第9期2458-2462,共5页Central South Pharmacy

基　　金：湖南省食品药品监督管理局食品药品安全科技项目(No.2021JJ80044)。

摘　　要：目的建立离子色谱法测定聚乙二醇6000中的10种有机酸和无机阴离子含量。方法采用IonPac AS11-HC(250 mm×4 mm,9μm)分析柱,以KOH淋洗液进行梯度洗脱,柱温30℃,流速1.0 mL·min^(-1),进样量25μL,选择电导检测器进行测定,外标法定量。结果在该色谱条件下,10种有机酸和无机阴离子的峰面积与质量浓度的线性关系良好(r≥0.999),平均回收率为93.4%~100.6%,RSD为0.60%~2.6%。结论本方法检出限低、重现性好,可用于聚乙二醇6000中有机酸和无机阴离子含量的控制。Objective To determine 10 organic acids and inorganic anions in polyethylene glycol 6000 by ion chromatography.Methods Ion chromatography was performed on IonPac AS11-HC column(250 mm×4 mm,9μm)in gradient elution with KOH solution.The column temperature was 30℃,the flow rate was 1.0 mL·min^(-1),and the injection volume was 25μL.All of the target compounds were detected by conductivity detection and quantified by the external standard method.Results Under this chromatographic condition,10 organic acids and inorganic anions showed good linearity(r≥0.999)within the test concentration.The average recoveries were at 93.4%~100.6%and the RSDs were at 0.60%~2.6%.Conclusion The method has low detection limit and good reproducibility,which can be used to determine the content of organic acids and inorganic anions in polyethylene glycol 6000.

关 键 词：聚乙二醇6000 有机酸 无机阴离子 离子色谱法 

分 类 号：R927[医药卫生—药学]