HPLC法测定富马酸二甲酯有关物质

发布时间：2018-03-02 12:14

  本文选题：富马酸二甲酯　切入点：有关物质　出处：《沈阳药科大学学报》2015年11期 　论文类型：期刊论文

【摘要】：目的建立高效液相色谱法测定富马酸二甲酯原料药中有关物质的方法。方法采用Thermo C18色谱柱,以乙腈-体积分数为0.05%的磷酸溶液(体积比为10∶90)为流动相,流速:1 m L·min-1,检测波长:211 nm,进样量:20μL,柱温:35℃。结果杂质A、B、C、D和富马酸二甲酯的定量限分别为0.009、0.036、0.014、0.073和0.020 mg·L-1,杂质A、B、C、D和富马酸二甲酯的线性分别为0.160~1.602、0.160~1.599、0.160~1.602、0.160~1.600和0.160~1.601 mg·L-1,杂质A、B、C、D的平均回收率分别为98.5%、98.5%、100.0%和98.6%。结论本法可作为富马酸二甲酯有关物质的测定方法。
[Abstract]:Objective to establish a high performance liquid chromatographic method for the determination of related substances in dimethyl fumarate raw materials. Methods Thermo C18 column was used. The mobile phase was composed of acetonitrile-phosphoric acid solution with volume fraction of 0.05% (volume ratio 10: 90). The flow rate was 1 mL 路min-1, the detection wavelength was 1: 211 nm, the sample size was 20 渭 L, the column temperature was 35 鈩，

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