Radiation sterilization of fluoroquinolones in solid state: Investigation of effect of gamma radiation and electron beam

The effect of gamma radiation from 60Co source and 2 MeV electron beam was studied on two fluoroquinolone antibiotics viz norfloxacin and gatifloxacin in the solid state. The changes in reflectance spectrum, yellowness index, vibrational characteristics, thermal behavior, UV spectrum, chemical potency (HPLC) and microbiological potency were investigated. ESR measurement gave the number of free radical species formed and their population. The nature of final radiolytic impurities was assessed by studying the HPLC impurity profile. Both norfloxacin and gatifloxacin were observed to be radiation resistant, and did not show significant changes in their physico-chemical properties. They could be radiation sterilized at a dose of 25 kGy.