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

A reversed-phase liquid chromatographic method was applied to study the sta bility of thimerosal in Cuban recombinant hepatitis B vaccine samples store d under different temperature conditions. Salicylic acid was used as intern al standard, it allowed one to determine the thimerosal in the presence of its degradation products. Good stability of the preservative was demonstrat ed in vaccine samples for as long as 6 years. The same results were obtaine d when the vaccine samples were incubated at 37 and 45 degreesC during 30 d ays. The results were in compliance with the microbiological test for deter mining the effectiveness of antimicrobial preservative in these samples. (C ) 2001 Elsevier Science BN. All rights reserved.