Choice of capillary electrophoresis systems for the impurity profiling of drugs

In order to develop a strategy for the impurity profiling of drugs, the possibilities of some capillary electrophoresis systems were investigated. A mixture containing a drug and some of its possible impurities has been used as a model problem. The test compounds were investigated by capillary zone electrophoresis (CZE) and by micellar electrokinetic chromatography (MEKC). The pH of the CZE buffer was varied; but the two stereoisomers could not be separated. Moreover, CZE is not suitable for neutral compounds. In MEKC, two different types of surfactants, sodium dodecyl sulphate (SDS) and cetyltrimethylammonium bromide (CTAB), have been used and the effect of type and concentration modifier on the separation and the elution window was studied. In the SDS system, both the resolution and the elution window could be increased considerably by the addition of modifier. The use of two MEKC systems of different selectivity seems to be a combination with high potential for the impurity profiling of drugs. (C) 1998 Elsevier Science B.V. All rights reserved.