A generic approach to the impurity profiling of drugs using standardised and independent capillary zone electrophoresis methods coupled to electrospray ionisation mass spectrometry

Vassort, Aurélie, Barrett, David A., Shaw, P. Nicholas, Ferguson, Paul D. and Szucs, Roman (2005) A generic approach to the impurity profiling of drugs using standardised and independent capillary zone electrophoresis methods coupled to electrospray ionisation mass spectrometry. Electrophoresis, 26 9: 1712-1723. doi:10.1002/elps.200410261


Author Vassort, Aurélie
Barrett, David A.
Shaw, P. Nicholas
Ferguson, Paul D.
Szucs, Roman
Title A generic approach to the impurity profiling of drugs using standardised and independent capillary zone electrophoresis methods coupled to electrospray ionisation mass spectrometry
Journal name Electrophoresis   Check publisher's open access policy
ISSN 1522-2683
0173-0835
Publication date 2005-03-30
Sub-type Article (original research)
DOI 10.1002/elps.200410261
Volume 26
Issue 9
Start page 1712
End page 1723
Total pages 12
Place of publication Weinheim
Publisher Verlag Chemie, GmbH
Language eng
Subject 320500 Pharmacology and Pharmaceutical Sciences
320501 Pharmaceutical Sciences and Pharmacy
Abstract Three standardised, capillary zone electrophoresis-electrospray ionisation mass spectrometry (CZE-ESI-MS) methods were developed for the analysis of six drug candidates and their respective process-related impurities comprising a total of 22 analytes with a range of functional groups and lipophilicities. The selected backround electrolyte conditions were found to be: 60/40 v/v 10 mM ammonium formate pH 3.5/organic, 60/40 v/v 10 mM ammonium acetate pH 7.0/organic and 10 mM piperidine, pH 10.5, where the organic solvent is 50/50 v/v methanol/acetonitrile. The coaxial sheath flow consisted of either 0.1% v/v formic acid in 50/50 v/v methanol/water, or 10 mM ammonium acetate in 50/50 v/v methanol/water, depending on the mixture being analysed. Factor analysis and informational theory were used to quantify the orthogonality of the methods and predict their complementarities. The three selected CZE-ESI-MS methods allowed the identification of 21 out of 22 of all the drug candidates and their process-related impurities and provided orthogonality with four established high-performance liquid chromatography-mass spectrometry (HPLC-MS) methods. These methodologies therefore form the basis of a generic approach to impurity profiling of pharmaceutical drug candidates and can be applied with little or no analytical method development, thereby offering significant resource and time savings.
Keyword Capillary zone electrophoresis
Impurity profiling
Liquid chromatography
Mass spectrometry
Orthogonality
Q-Index Code C1

Document type: Journal Article
Sub-type: Article (original research)
Collections: Excellence in Research Australia (ERA) - Collection
School of Pharmacy Publications
 
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