医药中间体富马酸含量测定中离子色谱法的应用分析

Application of Pharmaceutical Intermediates Fumarate Determination of Ion Chromatography

目的:研究分析医药中间体富马酸含量测定中离子色谱法的应用。方法:对在线淋洗液发生器产生的氢氧化钾溶液选用,将其作为淋洗液,并借助Dionex IonPacAS11-HC对柱阴离子进行分离实现交换分离,采取电导检测模式,并分离测定合成医药中间体的富马酸含量。结果:富马酸在0.10~100.0mg·L^(-1)线性关系较好(r=0.999 9),同时样品的保留时间、峰高的RSD以及峰面积全部都在1.05%以下,其检出限是0.014mg·L^(-1),测定中回收率为99.5%。采取离子色谱法对医药中间体富马酸含量进行测定,是一种简便、准确、快捷的方法,同时,离子色谱法在产品的检验中发挥着至关重要的作用。

Objective: To study the analysis of pharmaceutical intermediates fumaric acid content was measured in ion chromatography. Methods: potassium hydroxide solution choice for online eluent generator, which is used as the eluent, and by means of Dionex IonPacAS11-HC anion separation column separation enables the exchange to take conductivity detection mode, and the separation and determination of synthesis of pharmaceuticals intermediates fumarate content. Results: fumaric acid in 0.10 ~ 100.0mg·L^(-1) good linear relationship(r = 0.999 9), while the retention time of the sample, the peak height and peak area RSD all at 1.05% below its detection limit is 0.014 mg·L^(-1), assay recovery was 99.5%. Take ion chromatography pharmaceutical intermediates fumarate were determined, it is a simple, accurate and efficient way, while ion chromatography plays a vital role in product inspection.