Comparison of ICP-MS and ICP-OES for determination of aluminum in vaccine
10.19778/j.chp.2024.05.007
- VernacularTitle:ICP-MS与ICP-OES法测定疫苗中铝含量的比较
- Author:
Congcong LIU
1
;
Yuanheng LIN
;
Yanxiang YIN
;
Weiyang LIANG
;
Weiping WU
Author Information
1. 广东省药品检验所,广东省药品监督管理局血液制品质量控制研究重点实验室,国家药品监督管理局血液制品质量控制重点实验室,广州 510663
- Keywords:
ICP-MS;
ICP-OES;
aluminum;
vaccine;
adjuvant;
quantitative analysis
- From:
Drug Standards of China
2024;25(5):471-477
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To compare the test methods for aluminum content determination in vaccines by inductively coupled plasma-mass spectrometry(ICP-MS),inductively coupled plasma optical emission spectrometry(ICP-OES)and titration of the Chinese Pharmacopoeia 2020.Methods:The pre-treatment procedures,linearity,repeatability,accuracy,quantification limit,detection limit and sample determination results of the three methods were compared and analyzed by methodological verification and sample testing.Results:There was a good linear relationship of ICP-OES in the concentration range of 1-20μg·mL-1 aluminum content,r=0.9999.Aluminum content in 6 types of vaccines was in the range of 99％-104.6％,and RSDs were lower than 3％(n=9).There was a good linear relationship of ICP-MS in the concentration range of 2.5-80ng·mL-1(r=0.999).Aluminum content in 6 types of vaccines were in the range of 99.4％-108.9％,and RSDs were lower than 8％(n=9).There was no significant difference between the three methods in the determination of aluminum content in vaccines,and RSDs were lower than 10％.Conclusion:Both ICP-MS and ICP-OES methods can be used for the determination of alu-minum content in aluminum adjuvant vaccine.Both detection methods are simple,fast and accurate.ICP-OES has lower instrument costs and is easier to promote in the laboratory.
