Reversed-phase high-performance liquid chromatographic study of thimerosal stability in Cuban recombinant hepatitis B vaccine.
Non-degraded thimerosal was determined in the presence of its decomposition products by directly assaying recombinant hepatitis B vaccine using a reversed-phase liquid chromatographic method. Methanol-water-orthophosphoric acid (65:35:0.9, v/v/v) was used as the eluent. Salicylic acid was employed as an internal standard. The calibration graph was linear (r = 0.99995) up to 2.5 micrograms of thimerosal. Interference from aluminium hydroxide was eliminated by centrifugation. Good stability of thimerosal in the hepatitis B vaccine was demonstrated. The results obtained were in agreement with the recently proposed mechanism of degradation.
Tleugabulova
D
D
National Center for Bioproducts, Havana, Cuba.
González Perez
I
I
D000327:Adsorption; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D003462:Cuba; D004355:Drug Stability; D017325:Hepatitis B Vaccines / Q000032:analysis*; D011310:Preservatives, Pharmaceutical / Q000032:analysis*; D012015:Reference Standards; D013056:Spectrophotometry, Ultraviolet; D013849:Thimerosal / Q000032:analysis*; D014614:Vaccines, Synthetic / Q000032:analysis*
D017325:Hepatitis B Vaccines; D011310:Preservatives, Pharmaceutical; D014614:Vaccines, Synthetic; D013849:Thimerosal