Effect of gamma radiation on amlodis and its potential for radiosterilization.

Abstract

In the present work, radiation sensitivity of amlodis (AML) and its active ingredient Amlodipin Besylate (AML-B) were separately investigated by electron spin resonance (ESR) spectroscopy using radiolytic products induced in these drugs. Irradiation in the dose range of 2.5-25kGy did not create any ESR resonance line in AML-B, but it create five characteristic ESR resonance lines associated with more than one radical species in the case of AML. This signal is attributed to the radical species created upon irradiation of inactive ingredients such as microcrystalline cellulose and sodium starch glycolate of AML. Five resonance lines were observed to be divided into three sub groups of different characteristic behaviors associable with three different radical species. Radical species responsible from observed ESR lines were unstable at room and above room temperatures, however, they conserved their identities over a storage period of 92 days. This permitted to discriminate irradiated AML from unirradiated one. A quadratic function was found to describe best the variations of the intensities of observed resonance lines with applied radiation dose. A model based on three tentative radical species with a pyranose ring formed by the rapture of CH bonds in positions 1 and 4 was proposed to explain the observed five lines experimental ESR spectra. AML was considered not providing the characteristic features of a good dosimetric material due to its low radiation yield and relatively fast decays of the created radical species, but very low radiation sensitivity of its active ingredient, namely AML-B makes AML a good candidate for radiosterilization.

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