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Separation and quantitation of the four stereoisomers of itraconazole in pharmaceutical formulations by electrokinetic chromatography
Author(s) -
CastroPuyana María,
Crego Antonio L.,
Marina M. Luisa
Publication year - 2006
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/elps.200500347
Subject(s) - enantiomer , chromatography , itraconazole , resolution (logic) , electrokinetic phenomena , chemistry , phosphate buffered saline , chromatographic separation , stereochemistry , high performance liquid chromatography , antifungal , medicine , dermatology , artificial intelligence , computer science
The four stereoisomers of itraconazole were resolved for the first time by EKC using a CD as chiral selector. A study on the enantiomeric separation ability of different neutral CDs was carried out. Heptakis‐2,3,6‐tri‐ O ‐methyl‐β‐CD was shown to provide the highest values for the enantiomeric resolution. The influence of some experimental conditions, such as pH, chiral selector concentration, and temperature, on the enantiomeric separation was also studied. The use of a 100 mM phosphate buffer (pH 2.5), 30 mM in heptakis‐2,3,6‐tri‐ O ‐methyl‐β‐CD together with an applied voltage of 30 kV and a temperature of 20°C enabled the separation of the enantiomers of itraconazole with high resolutions ( R s > 3.0). Finally, the method was validated and successfully applied to the quantitation of itraconazole in three pharmaceutical formulations.