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盐酸多奈哌齐中基因毒性杂质的研究
Research of Genotoxic Impurities in Donepezil Hydrochloride
【摘要】 建立了液相色谱法测定盐酸多奈哌齐中的基因毒性杂质氯化苄的检测方法。该方法采用Waters Xterra RPl8色谱柱,用甲酸水溶液和乙腈作为流动相,梯度洗脱,在0.04~40μg/m L范围内线性关系良好,方法准确可靠,且具有较小的定量限(LOQ=1.3 ppm)。
【Abstract】 Benzyl chloride, a genotoxic impurity in donepezil hydrochloride, A liquid chromatography detection method has been developed about it, using Waters Xterra RPl8, aqueous formic acid and acetonitrile as mobile phase with gradient elution, ranging a good linear relationship at 0.04~40 μg/m L, accurate and reliable, and with a smaller limit of quantification(LOQ=1.3 ppm).
【关键词】 盐酸多奈哌齐;
基因毒性杂质;
测定研究;
氯化苄;
【Key words】 Donepezil Hydrochloride; genotoxic impuritie; determination of benzyl chloride;
【Key words】 Donepezil Hydrochloride; genotoxic impuritie; determination of benzyl chloride;
- 【文献出处】 广东化工 ,Guangdong Chemical Industry , 编辑部邮箱 ,2016年15期
- 【分类号】TQ460.72;O657.72
- 【下载频次】207