Simultaneous determination of propafenone and 5-hydroxypropafenone enantiomers in plasma by chromatography on an amylose derived chiral stationary phase

An enantioselective liquid chromatography method was developed for the simultaneous determination of propafenone (PPF) and 5-hydroxypropafenone (PPF-5OH) enantiomers in plasma. After liquid–liquid extraction with dichloromethane, the enantiomers were resolved on a Chiralpak AD column using hexane-et...

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Bibliographic Details
Published in:Journal of pharmaceutical and biomedical analysis 1999-06, Vol.20 (1), p.209-216
Main Authors: Pires de Abreu, Luis Renato, Lanchote, Vera Lúcia, Bertucci, Carlo, Cesarino, Evandro José, Bonato, Pierina Sueli
Format: Article
Language:English
Subjects:
5-Hydroxypropafenone
Amylose
Amylose derived chiral stationary phase
Anti-Arrhythmia Agents - blood
Anti-Arrhythmia Agents - pharmacokinetics
Antibacterial agents
Antibiotics. Antiinfectious agents. Antiparasitic agents
Biological and medical sciences
Calibration
Chromatography, High Pressure Liquid
Enantioselective LC analysis
Humans
Medical sciences
Methylene Chloride
Pharmacology. Drug treatments
Propafenone
Propafenone - analogs & derivatives
Propafenone - blood
Propafenone - pharmacokinetics
Reproducibility of Results
Solutions
Stereoisomerism
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Summary:An enantioselective liquid chromatography method was developed for the simultaneous determination of propafenone (PPF) and 5-hydroxypropafenone (PPF-5OH) enantiomers in plasma. After liquid–liquid extraction with dichloromethane, the enantiomers were resolved on a Chiralpak AD column using hexane-ethanol (88:12, v/v) plus 0.1% diethylamine as the mobile phase and monitored at 315 nm. Under these conditions the enantiomeric fractions of the drug and of its metabolite were analysed within 20 min. The extraction procedure resulted in absolute recoveries of 62.9 and 61.3% for ( R)- and ( S)-PPF, respectively, and of 57.6 and 56.5% for ( R)- and ( S)-PPF-5OH, respectively. This procedure was efficient in removing endogenous interferents as well the interference of an other PPF metabolite, N-despropylpropafenone (PPF-NOR). The calibration curves were linear over the concentration range 25–1250 ng/ml. Low values of the coefficients of variation were demonstrated for both within-day and between day assays. The method described in this paper allows the determination of PPF and PPF-5OH enantiomers at plasma levels as low as 25 ng/ml and can be used in clinical pharmacokinetic studies.
ISSN:0731-7085
1873-264X
DOI:10.1016/S0731-7085(99)00022-9