Development of a chiral HPLC method for the analysis of naftopidil enantiomers

手性高效液相色谱法测定萘哌地尔对映异构体(英文)

We developed a chiral HPLC method for the separation and analysis ofnaftopidil enantiomers. The two enantiomers of naflopidil 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-naflopidil 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 naflopidil enantiomers can be used for the quality control of synthesized naflopidil product.

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。