Research paper
Radio sterilization dosimetry by ESR spectroscopy: Ritodrine hydrochloride and comparison with other sympathomimetics

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Abstract

The use of ionizing radiation for sterilization of pharmaceuticals is now a well-established technology. The purpose of the present work was to apply the ESR spectroscopy to the irradiation dosimetry of ritodrine hydrochloride. Numerical simulation of the free radicals dependence on dose at ambient temperature was performed using five models. The best fit between experimental and calculated values for a dose range of 0–50 kGy was obtained with a polynomial function and the Hill function. These five models were applied to five other sympathomimetics (terbutaline, fenoterol, orciprenaline, salbutamol and isoproterenol) with the same conclusion. Decay of radicals upon storage was performed using a bi-exponential model. Discrimination from irradiated to unirradiated samples by ESR is possible even after a storage of several months. HPLC evidenced the formation of radiolytic products after gamma-irradiation. Ritodrine hydrochloride showed a degradation of 2.8% at 25 kGy.

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