Abstract
Enantiomers of disopyramide (DP) and its mono-N-dealkylated metabolite (MND) were determined in human plasma and urine by enantioselective high-performance liquid chromatography using a chiral stationary-phase column. This method was precise and sensitive: the mean recoveries from plasma at a concentration of 0.5 μg/ml were 101.1% for (+)-DP, 98.0% for (−)-DP, 94.4% for (+)-MND and 82.9% for (−)-MND; the within- and between-day coefficients of variation at the same concentration were 4.4 and 3.3% for (+)-DP, 4.7 and 4.1% for (−)-DP, 6.5 and 4.1% for (+)-MND and 7.8 and 2.4% for (−)-MND for plasma; the lower detection limits were 40 ng/ml for (+)-DP, 80 ng/ml for (−)-DP, 100 ng/ml for (−)-MND and 200 ng/ml for (+)-MND, for 0.5 ml of plasma and 0.2 ml of urine. The ultrafiltration technique was used for determination of the unbound concentration of DP enantiomers in plasma. A preliminary study of the determination of DP and MND enantiomers in plasma and urine samples from a healthy subject given racemic DP demonstrated the clinical applicability of the present method for therapeutic monitoring and pharmacokinetic studies.
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