Carlson M, Thompson R D, Snell R P
U.S. Food and Drug Administration, Pharmaceutical Analysis Section, Minneapolis, Minnesota 55401.
J Chromatogr Sci. 1988 Nov;26(11):574-8. doi: 10.1093/chromsci/26.11.574.
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.
描述了一种用于药物制剂中硝酸异山梨酯的高效液相色谱（HPLC）测定法。该方法采用反相C18柱，流动相包含甲醇/水/醋酸盐缓冲液，相对于其2-和5-单硝酸盐降解产物及其他有机多硝酸酯，对硝酸异山梨酯具有特异性。该方法适用于稀释后的原料药和剂型的分析，包括舌下、口服、咀嚼和缓释制剂。
