TY - JOUR
T1 - Determination of the inorganic degradation products sulfate and sulfamate in the antiepileptic drug topiramate by capillary electrophoresis
AU - Klockow-Beck, A.
AU - Nick, A.
AU - Geisshuesler, St
AU - Schaufelberger, D.
N1 - Copyright:
Copyright 2007 Elsevier B.V., All rights reserved.
PY - 1998/12/11
Y1 - 1998/12/11
N2 - A capillary electrophoresis (CE) method has been developed as an alternative method for the determination of the inorganic degradation products sulfate and sulfamate in topiramate drug product and drug substance, currently performed by ion chromatography. The anions are separated in a background electrolyte containing potassium chromate and boric acid, followed by indirect UV detection. By adding tetradecyltrimethylammonium bromide to the electrolyte, analysis is performed under co-electroosmotic flow conditions. Variations in injection volumes and migration times are compensated for by use of an internal standard. The validation of the method, which was performed according to ICH guidelines (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) , comprises specificity, accuracy, linearity, precision, sensitivity and robustness. In addition, the results of an actual tablet sample analysis obtained by this CE method are statistically shown to be in close agreement with those obtained by an ion chromatographic method. Copyright (C) 1998 Elsevier Science B.V.
AB - A capillary electrophoresis (CE) method has been developed as an alternative method for the determination of the inorganic degradation products sulfate and sulfamate in topiramate drug product and drug substance, currently performed by ion chromatography. The anions are separated in a background electrolyte containing potassium chromate and boric acid, followed by indirect UV detection. By adding tetradecyltrimethylammonium bromide to the electrolyte, analysis is performed under co-electroosmotic flow conditions. Variations in injection volumes and migration times are compensated for by use of an internal standard. The validation of the method, which was performed according to ICH guidelines (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) , comprises specificity, accuracy, linearity, precision, sensitivity and robustness. In addition, the results of an actual tablet sample analysis obtained by this CE method are statistically shown to be in close agreement with those obtained by an ion chromatographic method. Copyright (C) 1998 Elsevier Science B.V.
KW - Sulfamate
KW - Sulfate
KW - Topiramate
UR - http://www.scopus.com/inward/record.url?scp=0032509167&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0032509167&partnerID=8YFLogxK
U2 - 10.1016/S0378-4347(98)00365-X
DO - 10.1016/S0378-4347(98)00365-X
M3 - Article
C2 - 9892076
AN - SCOPUS:0032509167
SN - 1572-6495
VL - 720
SP - 141
EP - 151
JO - Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
JF - Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences
IS - 1-2
ER -