Dill D N, Eilbacher B
MERZ & Co. GmbH & Co. Research Laboratories, Frankfurt/Main 1 Germany.
J Chromatogr. 1993 Mar 5;613(1):150-7. doi: 10.1016/0378-4347(93)80209-m.
A gas chromatographic method with mass-selective detection for the determination of bifemelane in human plasma has been developed. The assay is based on a single hexane extraction and an efficient gas chromatographic separation on a capillary column. The assay has been validated and used to support clinical pharmacokinetic studies. The lowest limit of quantitation was found to be 1 ng/ml and allowed pharmacokinetic evaluation of the drug at doses down to 50 mg.
已开发出一种采用质量选择性检测的气相色谱法来测定人血浆中的比芬美兰。该测定法基于单次己烷萃取以及在毛细管柱上进行的高效气相色谱分离。该测定法已经过验证,并用于支持临床药代动力学研究。定量下限为1 ng/ml,可对低至50 mg剂量的药物进行药代动力学评估。