International Scholarly Research Notices / 2012 / Article / Tab 2 / Research Article
Degradation Pathway for Eplerenone by Validated Stability Indicating UP-LC Method Table 2 Summary of forced degradation results.
Stress condition % Total impurities Study time % Assay of active substance Mass balance (% assay + % impurities + % degradation products) Remarks Acid hydrolysis (1 M HCI) 8.4% 2 h 91.4 99.8 Prominent degradation observed Base hydrolysis (0.5 M NaOH) 19.8% 1 h 79.7 99.5 One major degradation product was formed RRT about 0.31 and identified as “Methyl hydrogen 9, 11 dihydroxy, 17-α -hydroxy-3-oxopregn 7-α -carbonate, 21-α -carboxylic acid” Oxidation (15% H2 O2 ) 19.2% 4 h 78.5 97.7 Prominent Degradation observed Thermal (100° C) 0.3% 7 days 99.3 99.6 No degradation products formed Light (photolytic degradation) 0.4% 1200 KLUX/Hr 99.1 99.5 No degradation products formed
