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目的:建立分离测定血浆中普罗帕酮(PPF) 对映体浓度的HPLC方法,为临床对PPF对映体的药动学研究提供分析技术.方法:用乙酰葡萄糖异硫氰酸酯(GITC) 作手性衍生化试剂,产生非对映异构体.以含0 .01 ％ 冰醋酸的乙腈－ 水(3∶2)为流动相.采用内标法,紫外检测波长为210NM .结果:实验表明,R－ PPF与S－ PPF的分离度好.日内、日间的RSD 均小于11 ％ .血药浓度在50 ~500NG?ML－1 范围内呈线性关系,R ＞ 0.996 .结论:本方法可用于分离测定血浆中普罗帕酮对映体并适用于PPF的药动学研究“,”AIM To establish a convenient and sensitive HPLC method for separation and determination of the enantiomers of propafenone(PPF) in human plasma, and to provide a scientific analytical technique for the studies of the pharmacokinetics for those Chinese oftaking PPF enantiomers.METHOD The method was based on derivatization with the chiral reagent 2,3,4,6-tetra-o-acetyl-β-D-glucopyranosyl isothiocyanate (GITC), and resolution of the resulting diastereomeric thioureas by reversed-phase HPLC, using acetonitrite-water(3∶2) containing 0.01% acetic acid as the mobile phase.The detection wavelength was 210 nm, Li-1115 was used as the internal standard.RESULTS The separation of the PPF enantiomers and I.S. was proved to be highly satisfactory. The accuracy (percentage error) was excellent.Both RSD of intra-day and inter-day were less than 11%. The assay linearity was determined over the range of 50~500ng·ml -1 in plasma(r>0.996).CONCLUSION This method possesses high accuracy and precision, and is sensitive and specific.The applicability of the assay to the pharmacokinetic studies of the enantiomers of PPF is also demonstrated.