CE-EMMA法测定乙脑灭活疫苗中乙二胺四乙酸二钠残留量
Determination of residual EDTA-2Na in Japanese encephalitis attenuated live vaccine by capillary electrophoresis with electrophoretically mediated microanalysis
吴金凤 1白建秋 1刘卫 1林瑶 1姜廷福2
作者信息
- 1. 山东恒业生物技术有限公司,山东青岛 266114
- 2. 中国海洋大学医药学院,山东青岛 266003
- 折叠
摘要
目的:建立毛细管电泳(CE)结合电泳中介微分析(EMMA)测定乙脑灭活疫苗中乙二胺四乙酸二钠(EDTA-2Na)残留量的方法.方法:运行缓冲液为0.025 mol·L-1磷酸氢二钠缓冲液(pH 2.5),在线络合金属离子为1.5 mg·mL Fe3+,孵育时间3 min,分离电压-25 kV,紫外检测波长257 nm,压力进样5 000 Pa× 5 s,检测温度为25.0℃.结果:EDTA-2Na在0.01～0.5 mg·mL-1的浓度范围内呈现良好的线性关系,r为0.999 9,最低检测限为5 μg·mL-1,测定样品RSD小于2.87％,加样回收率为94.13％～105.56％.结论:该方法操作简便,准确度高,稳定性好,可用于乙脑灭活疫苗中EDTA-2Na残留量的测定.
Abstract
Objective:To establish a capillary electrophoresis(CE)with electrophoretically mediated microanaly-sis(EMMA)method for the determination of EDTA-2Na in Japanese encephalitis attenuated live vaccine.Methods:The test was performed in disodium hydrogen phosphate buffer with pH 2.5,the online metal ions com-plexation of 1.5 mg·mL-1 Fe3+and incubation time of 3 min.The separation voltage was 25 kV,the detection wavelength was 257 nm,and.the column temperature was 25.0 ℃.Results:The established method had a good linear relationship in the concentration range of 0.01-0.5 mg·mL-1(r=0.999 9),the detection limit was 5 μg·mL-1,and the relative standard deviation(RSD)of the measured samples was less than 2.87％.The recoveries of spiked samples were between 96.49％-101.02％.Conclusion:The optimized method was applied to the determination of EDTA-2Na in Japanese encephalitis attenuated live vaccine.The satisfactory experimental results were obtained.
关键词
毛细管电泳/电泳中介微分析/乙脑灭活疫苗/乙二胺四乙酸二钠/残留量/质量控制Key words
capillary electrophoresis/electrophoretically mediated microanalysis/Japanese encephalitis attenuated live vaccine/EDTA-2Na/residual quantity/quality control引用本文复制引用
基金项目
2018年青岛市自主创新重大专项(18-1-1-91-nsh)
出版年
2024
NETL
NSTL
万方数据