Development and validation of a capillary electrophoresis assay for the determination of 3,4-diaminopyridine and 4-aminopyridine including related substances

Citation
S. Sabbah et Gke. Scriba, Development and validation of a capillary electrophoresis assay for the determination of 3,4-diaminopyridine and 4-aminopyridine including related substances, J CHROMAT A, 907(1-2), 2001, pp. 321-328
Citations number
22
Categorie Soggetti
Chemistry & Analysis","Spectroscopy /Instrumentation/Analytical Sciences
Journal title
Volume
907
Issue
1-2
Year of publication
2001
Pages
321 - 328
Database
ISI
SICI code
Abstract
A capillary electrophoresis (CE) assay has been developed for the quantitat ion and determination of the impurity profile of the potassium channel bloc kers 3,4-diaminopyridine and 4-aminopyridine. The compounds were separated from related substances using a capillary of 30 cm effective length, a 50 m M phosphate buffer, pH 2.5 and an applied voltage of 25 kV. The assay was v alidated with respect to specificity, linearity, range, limits of quantitat ion and detection, precision and robustness, The method allows the detectio n and quantitation of impurities at the 0.05% level. The feasibility of the assay was demonstrated by analyzing a commercial sample of 3,4-diaminopyri dine, All known related substances could be detected in this sample with th e present CE method. (C) 2001 Elsevier Science B.V. All rights reserved.