Gas chromatography-mass spectrometry determination of isosorbide 5-mononitrate and related impurities in raw materials and dosage formulations

Abstract A straightforward quantitative method for gas chromatography-mass spectrometry determination of isosorbide 5-mononitrate (IS5MN) and its related impurities such as isosorbide (IS), isosorbide diacetate (ISDA) and isosorbide 2-acetate-5-nitrate (IS2A5N) in raw materials as well as in dosage formulations is developed. The recovery of these materials was found to be 100.4±2.4, 99.3±4.7, 97.8±5.2 and 100.1±3.1%, while the detection limits were 27.2, 1.26, 1.02 and 0.78 μg in dosage formulations for IS5MN, ISDA, IS2A5N, and IS, respectively. The applicability of the method was tested by analysing three different formulations of IS5MN.