Abstract
Corticosteroids are the most widely used class of anti-inflammatory medications in the pharmaceutical industry. There are several pharmaceutical dosage forms available using different corticosteroids. Topical steroids of varying potencies are available in creams, ointments, solutions and other vehicles. Chemical instability and drug degradation are the key quality concerns for these topical dosage forms. Nature of the dosage forms, excipient quality, product composition, and process optimization are some of the common factors which affect the stability of corticosteroids. This article describes drug degradation behavior of three different corticosteroids in different topical dosage forms. Drug degradation patterns of Hydrocortisone, Clobetasol propionate and Desonide formulations observed in stability studies of respective finished drug products under ICH recommended storage conditions were investigated. HPLC, UPLC-MS/MS methods were developed for the separation and characterization of impurities. The structural elucidation of the unknown impurities observed for these steroids and mechanistic consideration of potential degradation pathways has been discussed. Detailed discussion on the analytical methodologies is included as well.
Highlights
In the current article steroids Hydrocortisone, Clobetasol propionate and Desonide formulations were evaluated in the finished product dosage forms and impurity profiling by UPLC-MS/MS was performed
Hydrocortisone working standard and impurity standards were supplied by Tianjin Jinjin Pharmaceutical Company, China whereas Clobetasol propionate, Desonide, Dexamethasone, Betamethasone were procured from Teva Pharmaceuticals and from sigma Aldrich, USA
Significant amounts of the 17-ketosteroid (11) and small amounts of the acid (VI) were detected in samples stored at 50 ̊C in Hydrocortisone lotion
Summary
They are widely used as potent anti-inflammatory and immunomodulatory agents and formulated in several dosage forms (Figure 1) [1] [2] [3] [4]. In the current article steroids Hydrocortisone, Clobetasol propionate and Desonide formulations were evaluated in the finished product dosage forms and impurity profiling by UPLC-MS/MS was performed. Degradation pathways of Clobetasol propionate evaluated in ointment, lotion and topical solution. UPLC-MS/MS and NMR performed for the Characterization of the unknown impurities in the stability samples of the Pharmaceutical Dosage forms. During the stability sample analysis of Desonide lotion there was one unknown impurity observed which was characterized by UPLC-MS/MS analysis
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