DETERMINATION OF ISOSORBIDE MONONITRATE (ISMN) AND ITS TWO RELATED SUBSTANCES IN ISOSORBIDE MONONITRATE AND SODIUM CHLORIDE INJECTION

摘要

A high-performance liquid chromatography (HPLC) method has been developed for the determination of isosorbide mononitrate and its related substances in isosorbide mononitrate and sodium chloride injection. An C18 column (5μm, 250 ×4.6 mm) was used for the determination, with methanol and water (25:75,v/v)as the mobile phase at the flow rate of 1 mL min?1. The detection wavelength was 210 nm. The related substances were quantitated versus an external standard. The method was capable of resolving all of the two known related substances. The two related substances were isosorbide dinitrate (ISDN) and 2- isosorbide mononitrate (2-ISMN), respectively. The method was successfully applied to quantify related substances. The limits of detection of isosorbide mononitrate, isosorbide dinitrate and 2-isosorbide mononitrate (2-ISMN) were all 0.3ng. And the limits of quantitation of isosorbide mononitrate, isosorbide dinitrate and 2- isosorbide mononitrate (2-ISMN) were all 0.8ng. The method was found to be accurate, precise, specific, linear and sensitive, for the determination