中国药物评价2023，Vol.40Issue(6)：485-488,4.
基于LC-MS/MS法检测水痘减毒活疫苗中的红霉素残留
Detection of Residual Erythromycin in Live Attenuated Varicella Vaccine Based on LC-MS/MS Method
孙晓龙 1杨青 2黄舒佳 3王宇 3林超 3王洪波 1刘颖3
作者信息
- 1. 烟台大学药学院,山东烟台 264003
- 2. 首药控股(北京)股份有限公司,北京 100195
- 3. 中国食品药品检定研究院,北京 100050
- 折叠
摘要
Abstract
Objective:The aim of this study was to establish a LC-MS/MS method for the detection of residual erythromycin in live attenuated varicella vaccine.Methods:Erythromycin was extracted from live attenuated varicella vaccine with acetonitrile as protein pre-cipitator.The liquid phase separation was performed on Shiseido CAPCELL PAK C18 MG(150 mm ×2.0 mm,5μm)column with 0.1％formic acid aqueous solution and 0.1％formic acid acetonitrile solution as mobile phase for gradient elution.The flow rate was 0.3 mL· min-1,and the sample size was 10 μL.Positive ion mode of electron spray ionization(ESI)and scanning mode of multiple reaction moni-toring(MRM)were used for mass spectrometry detection.Results:The limit of detection(LOD)and limit of quantitation(LOQ)of erythromycin in live attenuated varicella vaccine respectively were 0.02 ng·mL-1 and 0.04 ng·mL-1,and the linear regression equation was Y=1.46 × 105X+1.12 ×104(r=0.999 6)in the concentration range of 0.04-40 ng·mL-1.The intraday and daytime precision of the method were less than 5％,and the accuracy of that was in the range of 95％-115.1％.The recovery and matrix effect of the method were in the range of 96.5％-100.0％and-20％-20％,respectively.Conclusion:In this study,the LC-MS/MS method that was used to detect residual erythromycin in live attenuated varicella vaccine have good specificity,high sensitivity and good reproducibili-ty,which could be used for the detection of residual erythromycin in this vaccine.关键词
液相色谱-串联质谱法(LC-MS/MS)/多重反应监测(MRM)/水痘减毒活疫苗/红霉素残留Key words
Liquid chromatography-tandem mass spectrometry(LC-MS/MS)/Multiple reaction monitoring(MRM)/Live attenuated varicella vaccine/Erythromycin residue分类
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孙晓龙,杨青,黄舒佳,王宇,林超,王洪波,刘颖..基于LC-MS/MS法检测水痘减毒活疫苗中的红霉素残留[J].中国药物评价,2023,40(6):485-488,4.
