用电感耦合等离子体质谱法测定钆特酸葡胺注射液中游离Gd^3+的含量  

Determination of the content of Gd^3+ in gadoteric acid meglumine salt injection by ICP-MS method

作　　者：王骐榕 陈洁仪 孙渺 陈玉平 杨峰 WANG Qirong;CHEN Jieyi;SUN Miao;CHEN Yuping;YANG Feng(Department of Inorganic Chemistry,School of Pharmacy,Naval Medical University,Shanghai 200433,China)

机构地区：[1]海军军医大学药学院无机化学教研室,上海200433

出　　处：《药学实践杂志》2020年第2期124-128,共5页Journal of Pharmaceutical Practice

基　　金：海军军医大学本科学员创新能力孵化基地项目(FH2018078)。

摘　　要：目的建立测定钆特酸葡胺注射液中Gd^3+含量的方法。方法电感耦合等离子体质谱(ICP-MS)法。分离柱为金属螯合柱(1-ml Chelating Sepharose column),柱温为常温,流速为1 ml/min,进样量为0.5 ml。ICP-MS的相对分子质量为157(Gd的相对分子质量为157),载气为氩气。结果回归方程为:Y=0.001 635X+0.000 000E+000(经过原点),r=1.000。线性范围为0~500μg/L;仪器精密度、稳定性、重复性、加样回收率试验结果均符合要求。结论该方法操作简便、结果准确、重复性好,可用于测定钆特酸葡胺注射液中Gd^3+的含量。Objective To establish a method for determining the content of Gd^3+ in gadoteric acid meglumine salt injection. Methods ICP-MS was used. The separation column was a metal chelate column(1-ml Chelating Sepharose column),column temperature was normal temperature. Flow rate was 1 ml/min. Injection volume was 500 μl. Atoms were measured by ICPMS with a molecular weight of 157(The molecular weight of Gd was 157). The carrier gas was argon. Results The linear range of Gd3+ mass concentration was 0-500 ng/ml(r=1.000);The precision, stability and repeatability of the sample recovery test were all in accordance with the requirements. Conclusion The method was simple in operation, accurate in results and good in repeatability,which could be used to determine the content of Gd^3+ in gadoteric acid meglumine salt injection.

关 键 词：电感耦合等离子体质谱法 钆特酸葡胺注射液 GD^3+ 含量测定 

分 类 号：R284.1[医药卫生—中药学]