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Determination of fenfluramine enantiomers in pharmaceutical formulations by capillary zone electrophoresis

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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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Authors and Affiliations

  1. Laboratorio Chimica del Farmaco, Istituto Superiore di Sanità, V. le Regina Elena 299, 00161, Roma, Italy

    R. Porrà

  2. Dipartimento di Studi Farmaceutici, Università di Roma “La Sapienza”, P. le A. Moro 5, Roma, Italy

    M. G. Quaglia

  3. Istituto di Cromatografia del C.N.R., Area della Ricerca di Roma, Monterotondo Scalo, P.O. Box 10, 00016, Roma, Italy

    S. Fanali

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  1. R. Porrà
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  2. M. G. Quaglia
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  3. S. Fanali
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Porrà, R., Quaglia, M.G. & Fanali, S. Determination of fenfluramine enantiomers in pharmaceutical formulations by capillary zone electrophoresis. Chromatographia 41, 383–388 (1995). https://doi.org/10.1007/BF02318609

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