Determination of residual EDTA-2Na in Japanese encephalitis attenuated live vaccine by capillary electrophoresis with electrophoretically mediated microanalysis

VernacularTitle:CE-EMMA法测定乙脑灭活疫苗中乙二胺四乙酸二钠残留量
Author: WU Jinfeng ; BAI Jianqiu ; LIU Wei ; LIN Yao ; JIANG Tingfu
Publication Type:Journal Article
Keywords: capillary electrophoresis; electrophoretically mediated microanalysis; Japanese encephalitis attenuated live vaccine; EDTA-2Na; residual quantity; quality control
From: Drug Standards of China 2024;25(1):025-029
CountryChina
Language:Chinese
Abstract: Objective: To establish a capillary electrophoresis (CE) with electrophoretically mediated microanalysis (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 complexation 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.
Full text:202408101321009015620240204.pdf