Determination of fenfluramine enantiomers in pharmaceutical formulations by capillary zone electrophoresis |
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Authors: | R Porrà M G Quaglia S Fanali |
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Institution: | (1) Laboratorio Chimica del Farmaco, Istituto Superiore di Sanità, V. le Regina Elena 299, 00161 Roma, Italy;(2) Dipartimento di Studi Farmaceutici, Università di Roma “La Sapienza”, P. le A. Moro 5, Roma, Italy;(3) Istituto di Cromatografia del C.N.R., Area della Ricerca di Roma, Monterotondo Scalo, P.O. Box 10, 00016 Roma, Italy |
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Abstract: | Summary Capillary zone electrophoresis has been used for the enantiomeric separation of racemic ortho-fenfluramine and meta-fenfluramine
employing a phosphate buffer at pH 2.5 added with cyclodextrins. The cyclodextrin type and concentration strongly influenced
the chiral resolution. The uncharged β-cyclodextrin polymer gave enantiomeric resolution of both ortho and meta isomers, while
γ-cyclodextrin was a good chiral selector for only ortho-fenfluramine; heptakis-2,3,6-tri-O-methyl-β-cyclodextrin permitted
base line separation of meta-fenfluramine enantiomers but only partial resolution of racemic ortho-fenfluramine. The optimized
electrophoretic method was applied to the quantitative analysis of 1-meta-fenfluramine (minor component in the mixture) and
d-meta-fenfluramine in a commercial pharmaceutical formulation. Good reproducibility for migration time and corrected peak
areas (R.S.D. <0.8% and <1.2%, respectively) was achieved and the presence of the minor component of the mixture was found
to be in accord to previous determinations performed by other analytical methods. |
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Keywords: | Capillary electrophoresis Enantiomer separation Cyclodextrins Pharmaceuticals Fenfluramine isomers |
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