title: Determination of isosorbide dinitrate in pharmaceutical products by HPLC.
abstract: A high-performance liquid chromatographic (HPLC) assay for isosorbide dinitrate in pharmaceutical formulations is described. The method employs a reversed-phase C18 column with a mobile phase containing methanol/water/acetate buffer and is specific for isosorbide dinitrate with respect to its 2- and 5-mononitrate degradation products and other organic polynitrate esters. The method is applicable to the analysis of the diluted bulk drug and dosage forms, including sublingual, oral, chewable, and timed-release preparations.
authors.affiliation: U.S. Food and Drug Administration, Pharmaceutical Analysis Section, Minneapolis, Minnesota 55401.
authors.forename: M
authors.initials: M
authors.lastname: Carlson
authors.forename: R D
authors.initials: RD
authors.lastname: Thompson
authors.forename: R P
authors.initials: RP
authors.lastname: Snell
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004304:Dosage Forms; D007548:Isosorbide Dinitrate / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000032:analysis*; D013056:Spectrophotometry, Ultraviolet
chemical_list: D004304:Dosage Forms; D004364:Pharmaceutical Preparations; D007548:Isosorbide Dinitrate