The effect of gamma radiation on the degradation of salbutamol.

The use of ionizing radiation for sterilization of pharmaceuticals is now a well established technology. Degradation of salbutamol was investigated after gamma irradiation using HPLC and ESR spectroscopy. HPLC evidenced the formation of radiolytic products after gamma irradiation. Salbutamol showed a degradation of nearly 2% at 25 kGy. Sterilization of salbutamol in the liquid state appeared not technically feasible. Simulation of the increase of free radicals versus dose was performed using linear and polynomial regression. These radicals could be detected even after a storage period of more than 12 months.