A rapid HPLC assay for the simultaneous determination of propafenone and its major metabolites in human serum.
A rapid and specific HPLC method has been developed and validated for the simultaneous determination of propafenone, an antiarrhythmic agent, and its major metabolites in human serum. The sample preparation was a simple deproteinization with a mixture of ZnSO4 and methanol, yielding almost 100% recoveries of three compounds. Separation was developed on a reverse-phase tracer excel C18 column (25 x 0.46 cm i.d., 5 microm), using an acetonitrile-phosphate buffer gradient at a flow rate of 1.7 ml min(-1), and UV detection of 210 nm. The calibration curves were linear (r2 > 0.999) in the concentration range of 10 - 750 ng ml(-1). The lower limit of quantification was 10 ng ml(-1) for all of the compounds studied. The within and between day precisions in the measurement of QC samples at four tested concentrations were in the range of 1.4 - 8.1% and 4.2 - 11.5% RSD, respectively. The developed procedure was applied to assess the pharmacokinetics of propafenone and its major metabolites following administration of a single 300 mg oral dose of propafenone hydrochloride to three healthy male volunteers.
Biopharmaceutics and Pharmacokinetics Division, Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, 14155-6451, Tehran, Iran.
Minoo
M
Afshar
Mohammadreza
M
Rouini
D000284:Administration, Oral; D000889:Anti-Arrhythmia Agents / Q000097:blood* / Q000378:metabolism*; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D008297:Male; D011405:Propafenone / Q000097:blood* / Q000378:metabolism*; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013997:Time Factors
D000889:Anti-Arrhythmia Agents; D011405:Propafenone