电感耦合等离子体-质谱法测定注射用益气复脉(冻干)中的硫元素

Determination of sulfur content in Yiqi Fumai Lyophilized Injection by ICP-MS

目的采用电感耦合等离子体-质谱(ICP-MS)法建立注射用益气复脉(冻干)中硫元素的含量测定方法。方法以微波消解法处理样品,硝酸为消解试剂,样品经微波消解后,以锗(Ge)元素为内标元素,采用ICP-MS法测定药液中硫元素的量。结果硫元素质量浓度在1~15μg/m L内线性关系良好(r=0.999 0);准确度试验(n=6)平均回收率为95.4%,RSD值为5.9%;结论该方法简便、快速、准确,可用于测定注射用益气复脉(冻干)中硫元素的含量,为其质量控制、安全性评价提供一定参考。

Objective To establish a method for determination of sulfur content in Yiqi Fumai Lyophilized Injection by ICP-MS.Methods The samples of Yiqi Fumai Lyophilized Injection with nitric acid system as digestion reagent were eliminated by microwave, the sulfur content of which were determined by ICP-MS using the Ge element as the internal standard. Result Good linearity（r = 0.999 0） was observed in the standard curves of sulfur element in the range of 1~15 μg/m L; The average recovery and RSD value of sulfur element in the accuracy experiments（n = 6） were 95.4% and 5.9%, respectively. Conclusion The method is simple, rapid and accurate, which can be used to determine the content of sulfur in Yiqi Fumai Lyophilized Injection, and provide the reference for its quality control and safety evaluation.