Comparison of chiral electrophoretic separation methods for phenethylamines and application on impurity analysis

A chiral microemulsion electrokinetic chromatography method has been developed for the separation of the enantiomers of the phenethylammes ephedrine, N-methylephedrine, norephedrine, pseudoephedrine, adrenaline (epinephrine), 2-amino-1-phenylethanol, diethylnorephedrine, and 2-(dibutylamino)-1-phenyl-1-propanol, respectively The separations were achieved using an oil-in-water microemulsion consisting of the oil-component ethyl acetate, the surfactant sodium dodecylsulfate, the cosurfactant 1-butanol, the organic modifier propan-2-ol and 20 mM phosphate buffet pH 2.5 as aqueous phase For enantioseparation sulfated beta-cyclodextrin was added The method was compared to an already described CZE method, which made use of heptakis(2,3-di-O-diacetyl-6-O-sulfo)-beta-cyclodextrin (HDAS) as chiral selector. Additionally, the developed method was successfully applied to the related substances analysis of noradrenaline, adrenaline, dipivefrine, ephedrine and pseudoephedrine monographed in the European Pharmacopoeia 6. (C) 2010 Elsevier B.V All rights reserved