DETERMINATION OF ISOSORBIDE DINITRATE IN PHARMACEUTICAL PRODUCTS BY HPLC

被引:8
作者
CARLSON, M
THOMPSON, RD
SNELL, RP
机构
[1] U.S. Food and Drug Administration, Pharmaceutical Analysis Section, Minneapolis, MN 55401, United States
关键词
Chromatographic Analysis--Liquid - Esters - Organic Compounds--Chromatographic Analysis;
D O I
10.1093/chromsci/26.11.574
中图分类号
Q5 [生物化学];
学科分类号
071010 ; 081704 ;
摘要
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.
引用
收藏
页码:574 / 578
页数:5
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