Capillary electrokinetic separation techniques for profiling of drugs and related products

Abstract

Capillary electrokinetic separation techniques offer high efficiency and peak capacity, and can be very useful for the analysis of samples containing a large variety of (unknown) compounds. Such samples are frequently met in impurity profiling of drugs (detection of potential impurities in a pharmaceutical substance or product) and in general sample profiling (determination of differences or similarities between samples). In this paper, the potential, merits, and limitations of electrokinetic separation techniques for profiling purposes are evaluated using examples from literature. A distinction is made between impurity profiling, forensic profiling and profiling of natural products, and the application of capillary zone electrophoresis, micellar electrokinetic chromatography, and capillary electrochromatography in these fields is discussed. Attention is devoted to important aspects such as selectivity, resolution enhancement, applicability, detection, and compound confirmation and quantification. The specific properties of the various electrokinetic techniques are discussed and compared with more conventional techniques as liquid chromatography.

The Role of Analytical Chemistry in the Safety of Drug Therapy

“…This importance can be illustrated by the fact that in the last decade no less than four books have been published dealing solely with impurity and degradant profiling of drugs [187][188][189][190]. In addition to these, book chapters [191][192][193], special issues in journals [194,195], and review papers dealing with general aspects [195][196][197][198][199][200][201], and the application of chromatographic (HPLC, TLC, GC) [194a,b,c,e, 202,203], CE and related electromigration methods [86,[204][205][206][207], hyphenated techniques [107, 118, 133, 134, 141-143, 162, 208-210], and NMR spectroscopy [194f] in drug impurity profiling are worth mentioning.…”

Safety and Efficacy: The Role of Chemistry, Manufacturing, and Controls in Pharmaceutical Drug Development

“…[39] Alternative separation techniques should also be employed and may include normal-phase HPLC, thin layer chromatography (TLC), and capillary zone electrophoresis (CZE). [40] The importance of adequate detection methods is magnified by the fact that the drug substance process typically undergoes changes during phase 1 and phase 2.…”

Capillary Electrophoresis as a Verification Tool for Immunochemical Drug Screening

“…All CE modes employ the same instrumentation; samples can be easily analyzed subsequently as diff erencing separation mechanisms. Generally, CE is a very promising tool for clinical analysis at the present time [14][15][16][17][18][19] and it could be a simple and less time-consuming alternative technique to HPLC and GC which are also based on diff erent separation mechanisms than CE. The selectivity of CE can be utilized for separation of complicated mixtures of target analytes (e.g.…”