ICP-MS determination of elemental impurities in pharmaceutical excipient sucrose
10.19778/j.chp.2024.04.017
- VernacularTitle:ICP-MS法测定药用辅料蔗糖中元素杂质的含量
- Author:
Mingzhen WU
1
;
Yue LI
;
Jianping ZHU
;
Zhuangwei LIU
;
Rui YANG
;
Xia ZHAO
Author Information
1. 广西壮族自治区药品检验研究院,南宁 530022
- Keywords:
sucrose;
pharmaceutical excipient;
inductively coupled plasma mass spectrometry(ICP-MS);
elemental impurities;
ICH Q3D
- From:
Drug Standards of China
2024;25(4):423-429
- CountryChina
- Language:Chinese
-
Abstract:
Objective:An ICP-MS method was established for the determination of arsenic(As),cadmium(Cd),mercury(Hg),lead(Pb),cobalt(Co),nickel(Ni),vanadium(V),lithium(Li),antimony(Sb),copper(Cu)and other 10 elements in pharmaceutical excipients sucrose to assess their risks.Methods:The pharmaceuti-cal excipient sucrose was dissolved in 0.1％HN03 solution directly,and the contents of 75 As,111Cd,202Hg,208Pb,59 Co,60 Ni,51V,7 Li,121 Sb,and 63 Cu in sucrose were determined by the ICP-MS method with the optimized instru-mental parameters in the STD mode.Results:The results showed that the linearity of the method was great in the range of 0-100 ng·mL-1 for As,Cd,Pd,Co,Ni,V,Li,Sb and Cu(the correlation coefficient r was not less than 0.99),and the linearity of the method was good in the range of 0-2 ng·mL-1 for Hg(r=0.999 1).The average recoveries for the 10 elements were in the range of 99.8％-100.0％,and the RSDs were less than 5％(n=6).Conclusion:The method is easy to operate and has high accuracy.It can be used for the determination of 10 elemental impurities in pharmaceutical excipient sucrose.It can be seen that the content of the above ten elements in sucrose is much lower than the specified value in ICH Q3D,and the risk is small.The heavy metal item can no longer be considered separately when revising the standard.
