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Determination of volatile amines in drug substances by capillary gas chromatography

✍ Scribed by de Haan, P. E. ;de Jong, D. ;van den Berg, J. H. M. ;Kruse, C. G.

Publisher
John Wiley and Sons
Year
1989
Tongue
English
Weight
355 KB
Volume
12
Category
Article
ISSN
0935-6304

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✦ Synopsis

The determination of small, water soluble amines such as aziridine and 2-chloroethylamine, in drug substances at trace levels is described. After removal of the bulk of the drug substance by extraction or precipitation, derivatization with acid chlorides is performed. In a two-phase (water-organic solvent) system, this derivatization reaction is accomplished almost simultaneously with the extraction of the product to the organic layer.The organic layer is analyzed by gas chromatography using on-column injection and selective detection. Detection limits are approx. 0.2 mg/ kg for aziridine and approx. 0.5 mg/kg for 2-chloroethylamine.

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