Evaluation of uncertainty in determination of cetrimonium bromide residue in polysaccharide vaccines by ultra performance liquid chromatography-mass spectrometry
10.13200/j.cnki.cjb.003975
- VernacularTitle:UPLC/MS-MS法检测多糖疫苗中十六烷基三甲基溴化铵残留量的不确定度评定
- Author:
LI Jingtao
- Publication Type:Journal Article
- Keywords:
Ultra performance liquid chromatography-mass spectrometry(UPLC/MS-MS);
Polysaccharide vaccines;
Cetrimonium bromide(CTAB);
Uncertainty
- From:
Chinese Journal of Biologicals
2023;36(8):987-991
- CountryChina
- Language:Chinese
-
Abstract:
Objective To determine the cetrimonium bromide(CTAB)residue in polysaccharide vaccines using ultra performance liquid chromatography-mass spectrometry(UPLC/MS-MS),and analyze and evaluate the uncertainty of the determination results.Methods By establishing a mathematical model,the sources and values of uncertainty introduced in the measurement process were analyzed,the uncertainty components of each influencing factor were calculated,and the standard uncertainty and expanded uncertainty were synthesized to form an uncertainty report.Results At 95% confidence interval,the expanded uncertainty was 0. 002 8 mg/kg. The determination result of CTAB residue in polysaccharide vaccine was reported as(1. 000 6 ± 0. 002 8)mg/kg(k = 2,confidence interval p = 95%).Conclusion The main factors affecting the accuracy of determination results are the preparation of standard solution and the introduction of recovery rate,which should be focused on and controlled in the experiment process to make the detection results more reliable.
