IC法测定盐酸多巴酚丁胺注射液中亚硫酸氢钠的含量

IC determination of sodium bisulfite in dobutamine hydrochloride injection

目的建立离子色谱抑制电导法测定盐酸多巴酚丁胺注射液中抗氧化剂亚硫酸氢钠含量的方法。方法采用IonPac AS11-HC(250 mm×4 mm,7μm)阴离子分析柱对样品进行分离,28.75 mmol·L-1氢氧化钠溶液为淋洗液,流速0.85 mL·min-1,抑制型电导检测器检测。样品经稀释后加三乙醇胺溶液2 mL,过0.45μm微孔滤膜后直接进样。结果亚硫酸氢钠浓度在5.09～35.69μg·mL-1线性关系良好(r=0.999);检测限为0.04μg·mL-1;样品平均回收率为98.1%(n=9)。结论本法简便、准确,灵敏度高,重复性好,可用于盐酸多巴酚丁胺注射液中亚硫酸氢钠的含量。

Objective To establish a suppressed conductivity ion chromatography method for the determination of theantioxidant sodium bisulfite in dobutamine hydrochloride injection.Methods The IonPac AS11-HC（250 mm×4 mm,7 μm） was used as an ion analytical column with the eluent of 28.75 mmol·L-1 sodium hydroxide for the separation.The flow rate was 0.85 mL·min-1 and the suppressed conductivity detector was adopted.The diluted sample solution was mixed with 2 mL of trolamine and the mixture was filtered through a 0.45 μm syringem embrane before injection.Results This method exhibited excellent regression（r=0.999） at 5.09-35.69 μg·mL-1.The detection limit was 0.04 μg·mL-1.The average recovery was 98.1%（n=9）.Conclusion The method is simple,accurate,sensible and reproducible,and can be used for the quality control of sodium bisulfite in dobutamine hydrochloride injection.