The Influence of Ionizing Radiation, Temperature, and Light on Eplerenone in the Solid StateReport as inadecuate




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BioMed Research InternationalVolume 2014 2014, Article ID 571376, 8 pages

Research Article

Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland

Department of Oncological Surgery II, Greater Poland Cancer Centre, Garbary 15, 61-866 Poznań, Poland

Department of Inorganic and Analytical Chemistry, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland

Received 10 June 2014; Accepted 11 July 2014; Published 4 August 2014

Academic Editor: Raid G. Alany

Copyright © 2014 Katarzyna Dettlaff et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Eplerenone was subjected to the influence of ionizing radiation in the form of a high-energy electron beam 25–400 kGy, high temperature 90°C RH 0% and 60°C RH 76.4%, and light 6 mln lux h. An HPLC method was used to determine the content of eplerenone and to establish the impurity profile of all samples. As eplerenone was found to be a compound of great resistance to the above stress factors with the exception of high doses of ionizing radiation ≥200 kGy when its degradation was above 1%, it is possible to sterilize eplerenone by radiation method with the standard dose of 25 kGy. Based on the analysis of impurities and degradation products, the mechanism of radiodegradation was demonstrated to differ from the mechanisms of photo- and thermodegradation. The observation that the DSC curves for the nondegraded and degraded samples of eplerenone were significantly different only under exposure to the electron beam confirmed the applicability of DSC for studies of radiolytic degradation of eplerenone.





Author: Katarzyna Dettlaff, Magdalena Ogrodowczyk, Witold Kycler, Agnieszka Dołhań, Barbara Ćwiertnia, Piotr Garbacki, and Anna J

Source: https://www.hindawi.com/



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