title: The influence of ionizing radiation, temperature, and light on eplerenone in the solid state.
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.
authors.affiliation: Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland.
authors.forename: Katarzyna
authors.identifier: 0000-0002-5986-7544
authors.initials: K
authors.lastname: Dettlaff
authors.affiliation: Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland.
authors.forename: Magdalena
authors.initials: M
authors.lastname: Ogrodowczyk
authors.affiliation: Department of Oncological Surgery II, Greater Poland Cancer Centre, Garbary 15, 61-866 Poznań, Poland.
authors.forename: Witold
authors.identifier: 0000-0001-7994-0756
authors.initials: W
authors.lastname: Kycler
authors.affiliation: Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland.
authors.forename: Agnieszka
authors.identifier: 0000-0002-4833-1429
authors.initials: A
authors.lastname: Dołhań
authors.affiliation: Department of Inorganic and Analytical Chemistry, . Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland.
authors.forename: Barbara
authors.initials: B
authors.lastname: Cwiertnia
authors.affiliation: Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland.
authors.forename: Piotr
authors.identifier: 0000-0002-2438-0525
authors.initials: P
authors.lastname: Garbacki
authors.affiliation: Department of Pharmaceutical Chemistry, Poznan University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland.
authors.forename: Anna
authors.initials: A
authors.lastname: Jelińska
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D000077545:Eplerenone; D008027:Light; D011839:Radiation, Ionizing; D013148:Spironolactone / Q000031:analogs & derivatives* / Q000737:chemistry / Q000528:radiation effects; D013242:Sterilization; D013696:Temperature
chemical_list: D013148:Spironolactone; D000077545:Eplerenone