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).
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)
出处
《华西药学杂志》
CAS
CSCD
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)。
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
Compound amino acid injection
Antioxidant
Sodium bisulfite
Ion chromatography
Conductivity detector
Sulfite
Sulfate
Content determination
