Determination of the partitioning, stability, and metabolite formation of isosorbide dinitrate in human and rat blood using an improved gas—liquid chromatographic assay

1998 ◽  
Vol 308 ◽  
pp. 153-164
Author(s):  
R Morrison
1977 ◽  
Vol 60 (6) ◽  
pp. 1341-1344
Author(s):  
David G Prue ◽  
Raymond N Johnson ◽  
Boen T Kho

Abstract A gas-liquid chromatographic (GLC) method is described for determining isosorbide dinitrate (ISDN) in tablets. ISDN is extracted from tablet excipients by a 2-phase system composed of water-ethyl ether, and detected and quantitated with a flame ionization detector after separation from the internal standard (glyceryl tributyrate) on a 3% OV-210 column. Ten replicate assays on 2 different batches of tablets, each containing 5 mg ISDN, gave coefficients of variation of 1.16 and 1.48%, respectively. Comparison of results obtained for tablets containing 5, 10, and 40 mg ISDN, and for diluted isosorbide dinitrate raw material containing 25% ISDN, showed good correlation among the GLC, USP colorimetric, and USP polarographic procedures. Assay of synthetic mixtures containing ISDN, isosorbide-2-mononitrate, and isosorbide-5-mononitrate demonstrated that the GLC procedure is specific for ISDN, whereas the USP polarographic procedure is subject to interference from the mononitrates.


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