Influence of radiation sterilization on the stability of trifluorothymidine.
The influence of radiation sterilization on the stability of trifluorothymidine (TFT) was investigated. TFT was irradiated under ambient atmosphere with a 60Co-source and with an electron accelerator at 25, 50, and 100 kGy, respectively. The radiation-induced effects were determined by chromatographic and spectroscopic methods as well as potentiometrically with a fluoride selective electrode. TFT was moderately stable to ionizing radiation. The degradation induced by electron-beam irradiation was significantly (P=95%) smaller than by gamma-irradiation. The radiolysis products amounted to about 0.25% after electron-beam irradiation at 25 kGy, and to about 0.50% after gamma-irradiation, respectively. The main irradiation product was 5-trifluoromethyluracil (TFMU). In addition five further impurities were detected with HPLC. Identification of degradation products was performed using HPLC-ESI-MS. A degradation path of TFT after radiation sterilization was shown.
Horsch
P
P
Department of Applied Biosciences, The Federal Institute of Technology, 117 M48 Winterthurerstr. 190, CH-8057, Zurich, Switzerland.
Bigler
L
L
Altorfer
H R
HR
D000998:Antiviral Agents / Q000528:radiation effects*; D002851:Chromatography, High Pressure Liquid; D004307:Dose-Response Relationship, Radiation; D004355:Drug Stability; D005720:Gamma Rays; D013242:Sterilization / Q000379:methods*; D013678:Technology, Pharmaceutical; D014271:Trifluridine / Q000528:radiation effects*
D000998:Antiviral Agents; D014271:Trifluridine