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建立一种手性高效液相色谱法分离与分析萘哌地尔对映异构体.采用AD-H(250 mm×4.6 mm,5 μm)色谱柱,检测波长为283 nm;流动相为正己烷-异丙醇-三乙胺(85∶15∶0.1,v/v/v);流速1.0 mL/min.萘哌地尔对映体得到良好分离,其R体和S体线性范围分别为0.78～50μg/mL(r=0.9999)和0.84～54μg/mL(r=0.9998),相应的日内及日间精密度不高于0.5%及0.7%.本文报道了萘哌地尔对映异构体的分离及测定方法,同时也可用于萘哌地尔合成对映体的纯度分析.“,”We developed a chiral HPLC method for the separation and analysis of naftopidil enantiomers. The two enantiomers of naftopidil were separated using a Chiralpak AD-H (250 mm×4.6 mm, 5 μm) column and monitored at the wavelength of 283 nm. The isocratic mobile phase consisting of hexane--isopropanol-diethylamine (85:15:0.1, v/v/v) was pumped at a flow rate of 1.0 mL/min. Under these chromatographic conditions, R-naftopidil and S-naftopidil were well separated and had good linearity in the ranges of 0.78-50 μg/mL (r=0.9999) and 0.84-54 μg/mL (r=0.9998), respectively. The relative standard deviations (RSD) of intra-and inter-day assays were no more than 0.5% and 0.7%, respectively. This improved method for the separation and quantitative determination of naftopidil enantiomers can be used for the quality control of synthesized naftopidil product.