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