郑曦孜

    重庆涵虚阁制药技术开发有限公司研发部，重庆 400064

    普拉康唑中四种光学异构体的HPLC法测定

    郑曦孜

    重庆涵虚阁制药技术开发有限公司研发部，重庆400064

    目的建立同时测定普拉康唑中4种光学异构体含量的方法。方法采用高效液相色谱法对普拉康唑中4种光学异构体的含量进行测定。色谱柱为Daice1 Chira1pak IC手性柱；流动相为正己烷∶乙醇(80∶20)，流速为1.0 mL/min；检测波长为210 nm；柱温为25℃。结果 4种光学异构体间分离度均大于1.5，检测质量浓度线性范围均为0.5～120 μg/mL(r≥0.9992)，方法回收率≥99.75%，RSD<1.50%(n=3)，检测限为0.15 μg/mL，3批普拉康唑样品中异构体的含量分别为批号151001：99.90%、0.02%、0.04%、0.04%；批号151002：99.89%、0.03%、0.05%、0.03%；批号151003：99.87%、0.02%、0.05%、0.06%。结论建立的方法准确、快速，实现了对普拉康唑光学异构体杂质的有效控制。

    普拉康唑；光学异构体；含量测定；高效液相色谱法

    [Abstract]Objective To estab1ish the method for determination of 4 kinds of enantiomers in Pramiconazo1e.Methods HPLC method was adopted to determine the content of 4 kinds of enantiomers in Pramiconazo1e.The determination was separated on Daice1 Chira1pak IC.The mobi1e phase was consisted of hexane-ethano1(80∶20)at a f1ow rate of 1.0 mL/ min and the co1umn temperature at 25℃.The detection wave1ength was 210 nm.Results The reso1ution of 4 kinds of enantiomers were greater than 1.5.The 1inear range of them were 0.5-120 μg/mL(r≥0.9992，n=8)with an recovery rate≥99.75%(RSD<1.50% ......