Investigation of radiosterilization of Benzydamine Hydrochloride by electron spin resonance spectroscopy

Abstract

The use of ionizing radiation for sterilization of pharmaceuticals is an attractive and growing technology. In the present work, the spectroscopic and kinetic features of the radicals induced in gamma irradiated solid Benzydamine Hydrochloride (BH) sample is investigated in the dose range of 3–34kGy at different temperatures using Electron Spin Resonance (ESR) spectroscopy. Gamma irradiated BH indicated eight resonance peaks centered at g=2.0029 originating from two different radical species. Decay activation energy of the radical mostly responsible from central intense resonance line was calculated to be 25.6±1.5kJ/mol by using the signal intensity decay data derived from annealing studies performed at high temperatures. A linear function of the applied dose was found to describe best the experimental dose-response data. However, the discrimination of irradiated BH from unirradiated one was possible even 3 months after storage at normal conditions. Basing on these findings it was concluded that BH and BH containing drugs could be safely sterilized by gamma radiation and that ESR spectroscopy could be successfully used as a potential technique for monitoring their radiosterilizations.