Determination of Isosorbide Nitrate and Its Analogues in Pharmaceuticals By High-Performance Liquid Chromatography

FANG-YING TSAI, CHIN-JUNG CHEN AND CHUN-SHENG CHIEN

National Laboratories of Foods and Drugs, Department of Health, Executive Yuan 161-2, Kuen Yang Street , Nangkang, Taipei, Taiwan, R.O.C.

ABSTRACT

   A reversed-phase column liquid chromatographic method was developed for analysis of isosorbide dinitrate (ISDN), isosorbide 5-mononitrate (IS5MN) and isosorbide 2-mononitrate (IS2MN) and its pharmaceuticals. Chromatography is performed to Bondclone ODS column using a mobile phase consisting of acetonitrile-PIC B6 buffer, pH 4.75 (13:87) with ultraviolet wavelength at 220 nm. The linearity calibration range was 0.05 mg/ml to 2.5 mg/ml (r=0.9999), and recoveries were generally greater than 98.0%.

Key words: Isosorbide dinitrate, Isosorbide 5-mononitrate, Isosorbide 2-mononitrate, HPLC.