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

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).