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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(250mm×4.6mm,5μm)色谱柱, 检测波长为283nm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0.78～50 μg/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。
To establish a chiral HPLC separation and analysis of enantiomers of naftopidil. The mobile phase with the wavelength of 283nm was n-hexane-isopropanol-triethylamine (85:15: 0.1, v / v / v) at a flow rate of 1.0 mL / min using an AD-H (250 mm × 4.6 mm, 5 μm) . The enantiomers of naftopidil were well separated and the linear ranges of R and S were 0.78-50 μg / mL (r = 0.9999) and 0.84-54 μg / mL (r = 0.9998), respectively. The corresponding intra- and inter- Precision not higher than 0.5% and 0.7%. This article reports the separation and determination of the enantiomers of naftopidil and the purity of the enantiomers of naftopidil.