Determination of isosorbide dinitrate in pharmaceutical products by HPLC.
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.
Carlson
M
M
U.S. Food and Drug Administration, Pharmaceutical Analysis Section, Minneapolis, Minnesota 55401.
Thompson
R D
RD
Snell
R P
RP
D002851:Chromatography, High Pressure Liquid; D004304:Dosage Forms; D007548:Isosorbide Dinitrate / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000032:analysis*; D013056:Spectrophotometry, Ultraviolet
D004304:Dosage Forms; D004364:Pharmaceutical Preparations; D007548:Isosorbide Dinitrate