Forced Degradation of Betamethasone Sodium Phosphate under Solid State: Formation, Characterization, and Mechanistic Study of All Four 17,20-Diastereomers of Betamethasone 17-Deoxy-20-Hydroxy-21-Oic Acid

Rapid structure elucidation of drug degradation products using mechanism-based stress studies in conjunction with LC–MSn and NMR spectroscopy: identification of a photodegradation product of betamethasone dipropionate

“…Even in cases where the supply of the samples is abundant, isolation of impurities at such minute amounts can be extremely tedious, timeconsuming, and difficult. To overcome these challenges, we have developed a strategy that combines LC-MS n , mechanism-based stress studies, semi-preparative HPLC purification and structure elucidation/confirmation by NMR spectroscopy to rapidly elucidate the structures of drug impurities, in particular drug degradation products [3][4][5]. The key step of this approach is the design of * Corresponding author.…”

Advances in the analysis of steroid hormone drugs in pharmaceuticals and environmental samples (2004–2010)

“…In the course of these studies online HPLC/UV and HPLC/MS(MS) with off-line MS and NMR after semi-preparative HPLC separation were used [38][39][40][41][42][43]. The main results were the identification of the epimeric 16␣-methyl derivative (dexamethasone-17-valerate) as a process impurity in betamethasone-17-valerate [38], the identification of 4 diastereomeric 17-deoxy-20-hydroxy-21-oic acid-type solidphase degradation products of betamethasone sodium phosphate [39] (see Fig. 1), identification of Z-and E-isomers of 20-hydroxy-17(20)-en-21-aldehyde degradation products and elucidation of the mechanism of their formation under acidic and basic stress conditions [40,41] (see Fig.…”

Studies on the Stability of Corticosteroids: Degradation of Clobetasol Propionate, Desonide and Hydrocortisone in Topical Formulations by HPLC and UPLC-MS/MS

“…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. Many authors proposed methods based on gas chromatography/mass spectrometry for the detection of corticosteroids [9] [14]- [26]. Hydrocortisone ( Figure 2) is used in treating severe allergies, arthritis, asthma, multiple sclerosis, and skin conditions.…”

“…There were several analytical methods that were developed for the Hydrocortisone estimation in creams and lotion dosage forms. Several articles are available about the degradation pathways of hydrocortisone in suspensions as well as in microbial environments [6] [9] [26] [27]. The current research article thoroughly reviewed about the degradation mechanism of the Hydrocortisone in the Hydrocortisone acetic acid otic solution in the stability conditions.…”

“…It was used in the treatment of skin conditions such as severe psoriasis, seborrheic dermatitis and extreme photo dermatitis in HIV/AIDS. There were articles described for the forced degradation of Clobetasol in bulk drug and cream formulations by HPLC [9] [30]. However there was no detailed degradation pathways of Clobetasol not been published to the best of our knowledge.…”