Identification, Characterization of Degradation Component in Desoximetasone Pharmaceutical Dosage Forms and Its Quantification in the Presence of Process Related Impurities

Topically used corticosteroids: What is the big picture of drug product degradation?

“…Furthermore, only TCA degraded to compound 6; a 21-glyoxilic PG ester which has been described in a study on a TCA ointment (van Heugten et al, 2018a). Solely DS degraded to compound 4; an anhydride which has been described in literature as an intermediate (Srinivasu et al, 2012). Interestingly, also a previously unreported 21aldehyde was found for DS.…”

“…The data described above was combined with all relevant literature to propose an overview of 20-keto-21-hydroxylcorticosteroid degradation in general (Hansen and Bundgaard, 1980;Li et al, 2009;Srinivasu et al, 2012;van Heugten et al, 2018a, b). Fig.…”

“…1 mentioned corticosteroid groups a small selection of for topical application relevant degradation products is described in literature. For triamcinolone acetonide (TCA) (van Heugten et al, 2018a;Wu et al, 2012) and hydrocortisone (HC) (Hansen and Bundgaard, 1980;Zhang et al, 2016) a 17-carboxylic acid and 21-aldehyde have been reported and for desoximethasone (DS) only a 17carboxylic acid (Srinivasu et al, 2012). Specifically for HC a 17-ketone and a 17-carboxylic acid and 21-aldehyde without the 17-hydroxide moiety have been described (Hansen and Bundgaard, 1980;Zhang et al, 2016).…”