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

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 formulati...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 1997-11, Vol.16 (3), p.425-429
Main Authors: Marinković, Valentina D, Milojković, Smiljana S, Nedeljković, Jovan M, Čomor, Jožef J, Agbaba, Danica, Živanov-Stakić, Dobrila
Format: Article
Language:English
Subjects:
Analysis
Biological and medical sciences
Drug Contamination
Gas Chromatography-Mass Spectrometry
General pharmacology
Isosorbide
Isosorbide 5-mononitrate
Isosorbide diacetate
Isosorbide Dinitrate - analogs & derivatives
Isosorbide Dinitrate - analysis
Isosorbide-2-acetate-5-nitrate
Medical sciences
Pharmacology. Drug treatments
Quality control
Regression Analysis
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Description
Summary: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.
ISSN:0731-7085
1873-264X
DOI:10.1016/S0731-7085(97)00079-4