离子色谱法测定复方氨基酸注射液(18AA)中的亚硫酸氢钠  

Determination of sodium bisulfite in Compound amino acid injection (18AA) by Ion chromatography

作　　者：邵天舒 周长明 李潇 郭雷 SHAO Tianshu;ZHOU Changming;LI Xiao;GUO Lei(NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine.Beijing Institute for Drug Control.Beijing,102206 P.R.China)

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

出　　处：《华西药学杂志》2021年第6期669-672,共4页West China Journal of Pharmaceutical Sciences

基　　金：国家科技重大专项(编号:2017zx09101001-007)。

摘　　要：目的采用离子色谱法测定复方氨基酸注射液(18AA)中抗氧剂亚硫酸氢钠的含量。方法采用Dionex Ion Pac AS11-HC分离柱(250 mm×4 mm, 9.0μm),以28 mmol·L^(-1)氢氧化钾溶液为淋洗液,等度淋洗,流速1.0 mL·min^(-1),柱温35℃,采用抑制型电导检测,抑制器电流75 mA。结果亚硫酸根和硫酸根的线性范围分别为0.06~6.48、0.012~1.2μg·mL^(-1),r分别为0.9996、0.9990;平均回收率为97.3%~99.1%,RSD为1.00%~1.55%(n=9)。结论所用方法准确、灵敏、重复性好,可为复方氨基酸注射液(18AA)中亚硫酸氢钠的用量控制提供参考。OBJECTIVE To establish an ion chromatography method for the determination of sodium bisulfite in Compound amino acid injection(18 AA).METHODS A Dionex Ion Pac AS11-HC chromatographic column was adopted, and 28 mmol·L^(-1)potassium hydroxide solution was used as elution at the flow rate of 1.0 mL·min^(-1).The test was conducted by a conductivity detector with the inhibition current of 75 mA and the column temperature of 35 ℃.RESULTS A good linear relationship was obtained of the peak areas against the concentrations of SO;and SO;in the range of 0.06-6.48 μg·mL^(-1)(r=0.9996) and in the range of 0.012-1.2 μg·mL^(-1)(r=0.9990),respectively.The average recovery was between 97.1% and 99.3%,with the RSD of 1.00%-1.55%(n=9).CONCLUSION The method is accurate, sensitive and reproducible, which can provide a reference for the control of the sodium bisulfite amount in Compound amino acid injection(18 AA).

关 键 词：复方氨基酸注射液 抗氧剂 亚硫酸氢钠 离子色谱法 电导检测器 亚硫酸根 硫酸根 含量测定 

分 类 号：R917[医药卫生—药物分析学]