Enantioselective analysis of sotalol in plasma by reversed-phase high-performance liquid chromatography using diastereomeric derivatives

A procedure for the concurrent determination of the (+)- and (−)-enantiomers of sotalol in plasma using high-performance liquid chromatography of diastereomeric derivatives is described. Sotalol is extracted from a 0.5-ml aliquot of plasma at pH 9.3 using ethyl acetate. Atenolol is used as the inter...

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Bibliographic Details
Published in:Journal of chromatography. B, Biomedical applications Biomedical applications, 1995-10, Vol.672 (1), p.89-96
Main Authors: Hooper, W.D., Baker, P.V.
Format: Article
Language:English
Subjects:
Adrenergic beta-Antagonists - blood
Adrenergic beta-Antagonists - pharmacokinetics
Chromatography, High Pressure Liquid - methods
Humans
Indicators and Reagents
Isocyanates
Naphthalenes
Reproducibility of Results
Sensitivity and Specificity
Sotalol - blood
Sotalol - pharmacokinetics
Spectrometry, Fluorescence
Stereoisomerism
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Summary:A procedure for the concurrent determination of the (+)- and (−)-enantiomers of sotalol in plasma using high-performance liquid chromatography of diastereomeric derivatives is described. Sotalol is extracted from a 0.5-ml aliquot of plasma at pH 9.3 using ethyl acetate. Atenolol is used as the internal standard. The ethyl acetate is removed under vacuum, and the residue derivatized with R-(−)-1-(1-naphthyl)ethyl isocyanate (NEIC, 0.005% in chloroform) in the presence of trace quantities of carbonate buffer. The chloroform is removed, the residue reconstituted in mobile phase (acetonitrile-water, 39:61, v/v), and an aliquot injected into the HPLC column. A C 18 trapping column is used to retain excess derivatizing reagent. While the derivatives are separated on a C 18 analytical column with the isocratic mobile phase mentioned above at 1.5 ml/min, the column-switching allows back-flushing of the trapping column to prepare for the next injection. The derivatives were detected using a fluorescence detector with excitation wavelength 280 nm and emission wavelength 320 nm. The method was fully validated, and shown to have excellent linearity, specificity, sensitivity, accuracy and precision. It has been applied to the determination of (+)- and (−)-sotalol in plasma from twelve subjects dosed with racemic sotalol.
ISSN:0378-4347
1572-6495
DOI:10.1016/0378-4347(95)00196-P