Determination of methylparaben, propylparaben, triamcinolone acetonide and its degradation product in a topical cream by RP-HPLC.
A novel reversed-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the determination of active component triamcinolone acetonide, its degradation product triamcinolone (occurring in formulation after long-term stability tests) and two preservatives presented in the cream-methylparaben and propylparaben, using hydrocortisone as an internal standard. The chromatographic separation was performed on a Supelco Discovery C18 column; the mobile phase for separation of all compounds consists of a mixture of acetonitrile and water (40:60 v/v). The analysis time was less than 9 min, at a flow rate of 0.6 mL min(-1) and detection at 240 nm. The method was found to be applicable for routine analysis (stability tests, homogeneity) in the pharmaceutical product topical cream Triamcinolon cream 0.1%.
Matysová
L
L
Department of Analytical Chemistry, Faculty of Pharmacy, Charles University, Heyrovského 1203, 500 05 Hradec Králové, Czech Republic.
Hájková
R
R
Sícha
J
J
Solich
P
P
D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000032:analysis* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid; D004355:Drug Stability; D005938:Glucocorticoids; D009824:Ointments / Q000737:chemistry; D010226:Parabens / Q000032:analysis; D011310:Preservatives, Pharmaceutical / Q000032:analysis*; D011786:Quality Control; D014221:Triamcinolone / Q000032:analysis*; D014222:Triamcinolone Acetonide / Q000032:analysis* / Q000737:chemistry
D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D009824:Ointments; D010226:Parabens; D011310:Preservatives, Pharmaceutical; D014221:Triamcinolone; C015358:methylparaben; D014222:Triamcinolone Acetonide; C006068:propylparaben