Reversed-phase high-performance liquid chromatography versus spectrophotometric assay for thimerosal in Cuban recombinant hepatitis B vaccine

被引:11
作者
Costa, L [1 ]
Vega, M [1 ]
Díaz, Y [1 ]
Marcelo, JL [1 ]
Hernández, JM [1 ]
Martino, T [1 ]
机构
[1] Ctr Genet Engn & Biotechnol, Havana 10600, Cuba
关键词
pharmaceutical analysis; stability studies; thimerosal; salicylic acid;
D O I
10.1016/S0021-9673(00)01073-6
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
A reversed-phase liquid chromatographic method was applied to study the stability of thimerosal in Cuban recombinant hepatitis B vaccine samples stored under different temperature conditions. Salicylic acid was used as internal standard, it allowed one to determine the thimerosal in the presence of its degradation products. Good stability of the preservative was demonstrated in vaccine samples for as long as 6 years. The same results were obtained when the vaccine samples were incubated at 37 and 45 degreesC during 30 days. The results were in compliance with the microbiological test for determining the effectiveness of antimicrobial preservative in these samples. (C) 2001 Elsevier Science BN. All rights reserved.
引用
收藏
页码:173 / 179
页数:7
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