Sensitive Analytical Method for Serum Primidone and Its Active Metabolites for Single-Dose Pharmacokinetic Analysis in Human Subjects

概要

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A sensitive method for determination of serum primidone (PRM) and its active metabolites, phenobarbital (PB) and phenylethylmalonamide (PEMA), was established to clarify the time-courses of serum PRM, PB and PEMA after a single oral administration of PRM to man. In this method, the serum was acidified and extracted with a mixture of chlorofrom-isopropanol (70 : 30).An aliquot of the organic phase was treated with 0.1 N sodium hydroxide to separate PRM and PEMA from PB and interfering substances. Then PRM and PEMA were simultaneously determined by reversed-phase high-performance liquid chromatography (HPLC) using a mixture of acetonitrile-water (12 : 88) as a mobile phase. PB was also determined by HPLC using a mixture of acetonitrile-phosphate buffer (19 : 81,pH 4.5) as a mobile phase after extraction with chloroform from the acidified aqueous alkaline phase. Sufficient accuracy and precision to determine submicrogram levels (50-1000 ng/ml) of serum PRM, PB and PEMA were obtained. By this method, serum PRM and its active metabolites were successfully measured for at least 5 d after a single 600 mg dose of PRM to a human subject.
社団法人日本薬学会の論文
1986-07-25