title: Development and validation of a reversed-phase liquid chromatographic method for analysis of degradation products of estradiol in Vagifem tablets.
abstract: A stability-indicating liquid chromatographic method for the determination of degradation products and impurities in Vagifem, estradiol vaginal tablets has been developed and validated. Vagifem is a low dose preparation containing only 25microg 17beta-estradiol in a tablet matrix of 80mg (a drug to excipient ratio of 1:3200). This paper presents the rationale for the optimization of the sample preparation in order to minimize placebo interference as well as validation data for linearity, accuracy, precision, ruggedness, specificity and limits of detection and quantification. Data shows that the method is suitable for routine analysis of minute amounts of estradiol impurities.
authors.affiliation: Analytical Development, CMC Development, Novo Nordisk A/S, Novo Nordisk Park, 2760 Maaloev, Denmark. lany@novonordisk.com
authors.forename: Lars
authors.initials: L
authors.lastname: Nygaard
authors.forename: Helle
authors.initials: H
authors.lastname: Drøhse Kilde
authors.forename: Steen G
authors.initials: SG
authors.lastname: Andersen
authors.forename: Lars
authors.initials: L
authors.lastname: Henriksen
authors.forename: Vivi
authors.initials: V
authors.lastname: Overby
mesh_terms: D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000592:standards; D004958:Estradiol / Q000032:analysis* / Q000737:chemistry; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards
chemical_list: D013607:Tablets; D004958:Estradiol