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Towards a general approach for the impurity profiling of drugs by micellar electrokinetic chromatography
Author(s) -
Hilhorst Martin J.,
Derksen Astrid F.,
Steringa Melle,
Somsen Govert W.,
de Jong Gerhardus J.
Publication year - 2001
Publication title -
electrophoresis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.666
H-Index - 158
eISSN - 1522-2683
pISSN - 0173-0835
DOI - 10.1002/1522-2683(200105)22:7<1337::aid-elps1337>3.0.co;2-8
Subject(s) - micellar electrokinetic chromatography , chemistry , chromatography , pulmonary surfactant , sodium dodecyl sulfate , micelle , bromide , selectivity , impurity , capillary electrophoresis , acetonitrile , analytical chemistry (journal) , aqueous solution , inorganic chemistry , organic chemistry , biochemistry , catalysis
A general micellar electrokinetic chromatographic (MEKC) strategy for the impurity profiling of drugs was developed involving a sodium dodecyl sulfate (SDS) and a cetyltrimethylammonium bromide (CTAB) MEKC system. With this combination, in principle, each sample component passes the detector in at least one of the two MEKC systems provided that separation buffers of the same pH are used in both systems. In order to select the proper MEKC systems, the electroosmotic flow (EOF) and micelle migration time ( t mc ) were determined for separation buffers of several pH values, containing various amounts of surfactant and organic modifier. The selectivity of the MEKC systems was studied using a mixture of compounds with a wide range of physico‐chemical properties. The final selection of two adequate MEKC systems for this approach was based on the requirements that the t mc ( i.e., analysis time) of both systems was below 20 min and that the t mc / t eof ratio was above 3 or 2 for the SDS and CTAB system, respectively. Furthermore, the systems should provide high efficiency, exhibit differences in selectivity and use moderate concentrations of modifier and surfactant, so that, if needed, further optimization is possible. The selected MEKC systems contained 60 m M SDS or 10 m M CTAB, respectively, in a phosphate buffer (pH 7.5) with 10% acetonitrile. Some test compounds with extreme mobilities were used to demonstrate the suitability of the MEKC approach to detect each component of a sample. The potential of the proposed MEKC combination for impurity profiling was demonstrated by the analysis of fluvoxamine with several impurities at the 0.1% level.