离子色谱法测定医药中间体富马酸的含量

Determination of Fumaric Acid in Pharmaceutical Intermediate by Ion Chromatography

摘要: 目的建立医药中间体富马酸的离子色谱分析方法。方法选用在线淋洗液发生器产生的KOH 为淋洗液，Dionex IonPac AS11-HC分离柱阴离子交换分离，电导检测模式，对用于合成医药中间体的富马酸进行分离测定。结果富马酸在0.10~100.0 mg·L^-1内线性良好(r=0.999 9)。样品的保留时间、峰面积和峰高的RSD均在1.05%以下(n=7)，检出限为0.014 mg·L^-1，回收率为98.8%~100.6%。结论本方法简便、快捷、准确，可以在产品检验中发挥重要作用。

Abstract: OBJECTIVE To develop an analytical method for the determination of fumaric acid in pharmaceutical intermediate product by ion chromatography. METHODS The determination of fumaric acid was achieved on a separation column IonPac AS11-HC with KOH as eluent, and the detection was performed by a conductivity detection mode. RESULTS The linear calibration was obtained over the range of 0.10-100.0 mg·L^-1 with a correlation coefficient of 0.999 9. The relative standard deviations(RSD) of retention time, peak area and peak height were 1ess than 1.05%(n=7). The detection limit of method was 0.014 mg·L^-1. The recoveries of added standard were 98.8%-100.6%. CONCLUSION The method is simple, fast and accurate for the determination of fumaric acid in the sample pharmaceutical intermediate.