title: Development and validation of a novel stability-indicating HPLC method for the simultaneous assay of betamethasone-17-valerate, fusidic acid, potassium sorbate, methylparaben and propylparaben in a topical cream preparation.
abstract: A novel stability-indicating reversed phase high performance liquid chromatographic (RP-HPLC) method for the simultaneous assay of betamethasone-17-valerate, fusidic acid and potassium sorbate as well as methyl- and propylparaben in a topical cream preparation has been developed. A 100mm×3.0mm ID. Ascentis Express C18 column maintained at 30°C and UV detection at 240nm were used. A gradient programme was employed at a flow-rate of 0.75ml/min. Mobile phase A comprised of an 83:17 (v/v) mixture of acetonitrile and methanol and mobile phase B of a 10g/l solution of 85% phosphoric acid in purified water. The method has been validated according to current International Conference on Harmonisation (ICH) guidelines and applied during formulation development and stability studies. The procedure has been shown to be stability-indicating for the topical cream.
authors.affiliation: Analytical Development Dept., mibe GmbH Arzneimittel, 06796 Brehna, Germany. Electronic address: jonathan.byrne@mibegmbh.de.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Byrne
authors.affiliation: Chemistry Dept., National University of Ireland Maynooth, Maynooth, Co. Kildare, Ireland.
authors.forename: Trinidad
authors.initials: T
authors.lastname: Velasco-Torrijos
authors.affiliation: Analytical Development Dept., mibe GmbH Arzneimittel, 06796 Brehna, Germany.
authors.forename: Robert
authors.initials: R
authors.lastname: Reinhardt
mesh_terms: D001624:Betamethasone Valerate / Q000032:analysis / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D004355:Drug Stability; D005672:Fusidic Acid / Q000032:analysis / Q000737:chemistry; D005938:Glucocorticoids; D010226:Parabens / Q000032:analysis / Q000737:chemistry; D011310:Preservatives, Pharmaceutical / Q000032:analysis / Q000737:chemistry*; D013011:Sorbic Acid / Q000032:analysis / Q000737:chemistry
chemical_list: D005938:Glucocorticoids; D010226:Parabens; D011310:Preservatives, Pharmaceutical; D005672:Fusidic Acid; D001624:Betamethasone Valerate; C015358:methylparaben; D013011:Sorbic Acid; C006068:propylparaben
keywords: Betamethasone-17-valerate; Development; Fusidic acid; HPLC; Preservatives; Validation