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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,DionexIonPac 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0.014mg.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。
Objective To establish a method of ion chromatography for the determination of fumaric acid in pharmaceutical intermediates. Methods The KOH generated by the on-line eluent generator was used as eluent. The Dionex IonPac AS11-HC column was used for anion exchange separation and conductivity detection. The fumaric acid used for the synthesis of pharmaceutical intermediates was isolated and determined. Results Fumaric acid showed a good linearity (r = 0.999 9) within 0.10-100.0 mg · L -1. The RSDs of the retention time, peak area and peak height of the samples were below 1.05% (n = 7). The detection limit was 0.014mg.L 1 and the recoveries were 98.8% ~ 100.6%. Conclusion This method is simple, fast and accurate and can play an important role in product inspection.