摘要
目的:建立了同时测定苯巴比妥钠注射液中玻璃安瓿瓶6种元素[硼(B)、钙(Ca)、铝(Al)、砷(As)、铅(Pb)、钡(Ba)]的迁移含量的电感耦合等离子体质谱(ICP-MS)方法。方法:采用硝酸作为消解溶剂,以微波消解法处理样品。以锂(Li)、锗(Ge)、铟(In)元素为内标元素,采用ICP-MS对6种元素含量进行测定,在线添加内标溶液对结果进行实时校正。结果:B在1~500 ng·ml^-1(r=1.000 0)、Ca在0.5~250 ng·ml^-1(r=1.000 0)、Al在1~500 ng·ml^-1(r=1.000 0)、As在0.1~50 ng·ml^-1(r=1.000 0)、Pb在0.1~50 ng·ml^-1(r=1.000 0)、Ba在1~500 ng·ml^-1(r=1.000 0)浓度范围内与峰面积均呈良好线性关系;6种元素的平均加样回收率分别为102.42%(RSD=0.95%),104.54%(RSD=0.48%),103.86%(RSD=1.48%),106.73%(RSD=1.33%),104.77%(RSD=1.19%),103.75%(RSD=0.97%)(n=9)。结论:该方法前处理过程简单,检出限低、快速准确,干扰小,可以同时测定苯巴比妥钠注射液中多种迁移元素的检测,更加有效控制苯巴比妥钠注射液的质量。
Objective: To establish a method for the simultaneous determination of six elements (B,Ca,Al,As,Pb and Ba) in glass ampoules of phenobarbital sodium injection by ICP-MS.Methods: Nitric acid was used as the digestion solvent and microwave digestion was used to treat the samples.With Li,Ge and In as the internal standard elements,the contents of the six elements were determined by ICP-MS,and the results were corrected by adding the internal standard solution online.Results: The linear range of B, Ca,Al,As,Pb and Ba was 1-500 ng·mL^-1 (r = 1.000 0),0.5-250 ng·mL^-1 (r = 1.000 0),1-500 ng·mL^-1 (r = 1.000 0),0.1-50 ng·mL^-1 (r = 1.000 0),0.1-50 ng·mL^-1 (r = 1.000 0) and 1-500 ng·mL^-1 (r = 1.000 0),respectively.The recovery of the six elements was 102.42%(RSD = 0.95%),104.54%(RSD = 0.48%),103.86%(RSD = 1.48%),106.73%(RSD = 1.33%), 104.77%(RSD = 1.19%) and 103.75%(RSD = 0.97%)(n = 9),respectively.Conclusion: The method has the advantages of simple pretreatment process,low detection limit,fast and accurate detection,and little interference.It can be used for the simultaneous determination of various migrating elements in phenobarbital sodium injection,and can control the quality of phenobarbital sodium injection more effectively.
作者
郭永辉
敦康
王润彪
闫凯
Guo Yonghui;Dun Kang;Wang Runbiao;Yan Kai(Hebei Institute for Food and Drug Control,Shijiazhuang 050011,China)
出处
《中国药师》
CAS
2019年第8期1549-1551,共3页
China Pharmacist
基金
2016年河北省科技计划项目(编号:16272610)
