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1 2013

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EPR studies of free radicals in thermally sterilized famotidine

Ramos P., Pilawa B., Stroka E.

Nukleonika

2013

Vol. 58, No. 3

413--418

Free radicals formation in thermally sterilized famotidine was studied by the use of an X-band (9.3 GHz) electron paramagnetic resonance (EPR) spectroscopy. The influence of temperature and time of sterilization on free radicals generated in famotidine was determined. The best sterilization conditions for the tested drug were found. Sterilization was done according to the pharmaceutical norms at temperatures 160°C (120 min), 170°C (60 min), and 180°C (30 min). It was pointed out that the optimal temperature of thermal sterilization for famotidine was 170°C and time of heating 60 min in this conditions the lowest free radicals concentration was found. The highest free radicals concentration was measured in famotidine heated at 160°C during 120 min, the long time of sterilization is responsible for this effect. Free radicals concentration changes during storage of famotidine after thermal sterilization. Its value increased with storage time for the drug sterilized at both temperatures of 170°C and 180°C. Free radicals concentration decreases from 7 days after sterilization. Complex system of free radicals with the shape of EPR lines, dependent on microwave power exist in thermally sterilized famotidine. Slow spin-lattice relaxation processes, strong dipolar interactions characterize thermally sterilized famotidine. Microwave saturation indicates that EPR lines of famotidine are homogeneously broadened. The usefulness of EPR spectroscopy to examine of the sterilized drugs was evaluated.