离子色谱法测定注射剂中4种常用水溶性抗氧剂的含量  

Determination of the content of four antioxidants in injections by ion chromatography

作　　者：高丛丛 李珉 侯金凤 车宝泉[1] 戴红[1] Gao Cong-cong;Li Min;Hou Jin-feng;Che Bao-quan;Dai Hong(Beijing Institute for Drug Control,MNPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine(Traditional Chinese Medicine),MNPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 100035)

机构地区：[1]北京市药品检验所,中药成分分析与生物评价北京市重点实验室,国家药品监督管理局仿制药研究与评价重点实验室,北京102206

出　　处：《中国抗生素杂志》2021年第3期262-264,I0003,共4页Chinese Journal of Antibiotics

基　　金：国家科技重大专项-重大新药创制项目(No.2017ZX9101001)。

摘　　要：目的建立一种离子色谱法测定注射剂中四种抗氧剂亚硫酸钠、亚硫酸氢钠、硫代硫酸钠和焦亚硫酸钠的方法。方法采用DionexIonPac AS11-HC(4mm×250mm)色谱柱,DionexIonPac AG11-HC(4mm×50mm)保护柱,以25mmol/L氢氧化钠溶液为淋洗液,流速1.0mL/min,抑制电流52mA,电导检测器检测,电导池温度35℃,柱温30℃。结果亚硫酸钠、亚硫酸氢钠在0.1~100μg/mL范围内线性关系良好,硫代硫酸钠和焦亚硫酸钠分别在0.08~100和0.05~100μg/mL范围内线性关系良好。检测限分别为0.02、0.02、0.04和0.01μg/mL,平均回收率在95%~102%,RSD均小于2%。结论本方法操作简便快速、准确、灵敏,适用于大部分注射剂中水溶性抗氧剂的检测。Objective A method for the determination of four antioxidants Na2SO3,NaHSO3,Na2S2O3,and Na2S2O5 in injections by ion chromatography has been established.Methods DionexIonPac AS11-HC(4mm×250mm)and DionexIonPac AG1-HC(4mm×50mm)were used to analyze samples with the eluent of 25mM sodium hydroxide solution.The flow rate was 1.0mL/min.The ASRS6004mm self-Regenerating Suppressor was adopted with the suppressor current set at 52mA.The conductivity pool was maintained at 35℃and the column temperature was at 30℃.Results The calibration curves of four antioxidants were all in good linearity,of which Na2SO3 and NaHSO3 were within the range from 0.1 to 100μg/mL,Na2S2O3 was within 0.08 to 100μg/mL,and 0.05 to 100μg/mL for Na2S2O5.The detection limits were 0.02,0.02,0.04,and 0.01μg/mL,respectively.The average recoveries were between 95%~102%,andthe relative standard deviation(RSD)values were<2%.Conclusion The method is simple,rapid,accurate,and sensitive,which is suitable for the detection of water-soluble antioxidants in most injections.

关 键 词：离子色谱法 注射剂 抗氧剂 

分 类 号：R978.1[医药卫生—药品]