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目的:建立毛细管电泳法,对左旋普拉克索中右旋普拉克索进行杂质检查。方法:分别以β-环糊精(β-CD)、羟丙基-β-环糊精(HP-β-CD)、硫酸酯-β-环糊精(SBE-β-CD)和二甲基-β-环糊精(DM-β-CD)为手性选择剂,考察手性选择剂的浓度、pH、柱长和柱内径对分离选择性的影响,采用未涂渍熔融石英毛细管47cm×50μm(有效长度40cm),背景电解质溶液:40mmol/L柠檬酸三钠缓冲液,含有0.5%SBE-β-CD,用磷酸调节pH值到4.0,柱温:30℃,检测波长254nm,电压16kV。结果:2种旋光异构体的分离度良好(Rs>2.5),样品中右旋普拉克索的含量均小于0.5%。结论:所建立的方法简单可靠、专属性强,可以作为常规的杂质检查手段。
OBJECTIVE: To establish a capillary electrophoresis method for impurity detection of dexpramipexole in levodropress. Methods: The effects of β-cyclodextrin (β-CD), hydroxypropyl-β-cyclodextrin (HP-β-CD) Β-cyclodextrin (DM-β-CD) was used as chiral selector. The effects of chiral selector concentration, pH, column length and column diameter on separation selectivity were investigated. 50μm (effective length 40cm), background electrolyte solution: 40mmol / L trisodium citrate buffer containing 0.5% SBE-β-CD, pH adjusted to 4.0 with phosphoric acid, column temperature 30 ℃, detection wavelength 254nm, 16kV. Results: The resolution of the two optical isomers was good (Rs> 2.5). The content of dexpramipexole in the samples was less than 0.5%. Conclusion: The established method is simple and reliable, specific and can be used as a conventional means of checking impurities.