Published:Journal of Chromatographic Science,
ISSN 0021-9665 Volume
45, Number 6, July 2007, pp.315-318
Validated, Stability-Indicated Quantitative Purity
Test for Triethylenetetramine Tetrachlorhydrate by Automated Multiple
Development
C. Dauphin, D. Poirier, and D. Pradeau
AGEPS, 7 Rue du Fer à Moulin, 75221 Paris Cedex 05, France
There is a monography of Triethylenetetramine dichlorhydrate
(Trientine) in the United States Pharmacopeia. But neither the
base nor the salts di- or tetra-chlorhydrate are in the European
Pharmacopeia. Triethylène tetramine tetrachlorhydrate,
used by
AGEPS now as matural, is more soluble then triethylene tetramine
dichlorhydrate. It is administred to patients with Wilson’s
disease, which results from a congenital lack of the copper metabolism.
A quantitative purity test of this drug by automated multiple
development high-performance thin-layer chromatography is developed
and validated. The validation parameters tested are specifically
characterized by retention factor, linearity, limits of detection
and quantitation of several nanograms, reliability, and accuracy. To determine impurities, the monography of triethylenetetramine
dichlorhydrate in the American Pharmacopeia is tested. This method
in classic developing tank requires two mobile phases and is not
quantitative. Assays in high-performance liquid chromatography
with a different column and mobile phase did not give good results
for the separation of impurities. Thus, it is not possible to
perform comparative validation of the separation of the impurities.
Only the assay of triethylenetetramine with potentiometer detection
has been validated.
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