The isolation and identification of some degradation products of flurandrenolide in Cordran cream

Development and validation of a stability-indicating HPLC-UV method for the determination of triamcinolone acetonide and its degradation products in an ointment formulation

“…The synthesis of Impurity C (compound 2, Fig. 1) was based upon a method described in literature [14]. Impurity C was synthesized by dissolving 600 mg TCA and 31.5 mg copper(II)acetate in 150 ml MeOH.…”

“…The PG hemi-acetal is described in literature as a comparable degradation product of triamcinolone acetophenonide in the presence of PG [16]. The C 17 -glyoxilic acid has been described before for flurandrenolide in a cream formulation only, but not for TCA or other described corticosteroids [2,14,15,17]. For the PG ester of the C 17glyoxilic acid no prior report was found.…”

The Role of Excipients in the Stability of Triamcinolone Acetonide in Ointments

“…Ointment was prepared and stored in closed glass containers Triamcinolone acetonide (TCA) and two degradation product as described for TCA and similar corticosteroids (2)(3)(4)(5) at 60°C for 1 month. Samples were analyzed using LC-MS.…”

“…This 21-aldehyde is formed by a reaction between TCA and molecular oxygen (O 2 ) that is catalyzed by metal salts (4). Second, for hydrocortisone and flurandrenolide the formation of a 17-carboxylic acid in alkaline environment was demonstrated by using O 2 and OH − as reagents (2,3). Other degradation products concern degradation of the A ring (6)(7)(8) or hydrolysis of the acetonide moiety (9).…”

“…This particular degradation predominantly occurs at the 17-side chain of the corticosteroid molecules (2)(3)(4)(5). Amongst other degradation products, two are the most often mentioned for corticosteroids with the same 17-side chain as TCA (Fig.…”