离子色谱法测定盐酸多巴酚丁胺注射液中亚硫酸氢钠含量

IC determination of sodium hydrosulfite in dobutamine hydrochloride injection

目的:建立测定盐酸多巴酚丁胺注射液中亚硫酸氢钠含量的抑制型离子色谱方法。方法:采用IonPacAG11-HC(250mm×4.0 mm)色谱柱,以30 mmol·L-1氢氧化钠为淋洗液,流速为1.0 mL·min-1,抑制器电流为100 mA。结果:亚硫酸氢钠在1.0～10.0 mg·L-1(r=0.9997)范围内有良好的线性响应关系,平均回收率(n=9)为98.7%,RSD为1.5%,最低检出限为0.05 mg·L-1。结论:本方法准确、简便、快速,可用于注射液中亚硫酸氢钠的快速测定。

Objective：To establish a suppressed conductive ion chromatography method for the determination of sodium hydrosulfite in dobutamine hydrochloride injection.Methods：Chromatographic separation was achieved on an IonPacAG11-HC（250 mm×4.0 mm） column with 30 mmol·L-1NaOH elution at the flow rate of 1.0 mL·min-1.The suppressor was operated at a current of 100 mA.Results：The linear range of sodium hydrosulfite was 1.0-10.0 μg·mL-1（r=0.9997）.The average recovery was 98.7% with an RSD of 1.5%（n=9）.The detection limit was 0.05 mg·L-1.Conclusion：The method is accurate,convenient and rapid,which provides a reliable way for the determination of sodium hydrosulfite in injection.