| 引用本文: | 李军荣,叶明立,曾雪灵,钟乃飞.离子色谱法测定医药中间体富马酸的含量[J].中国现代应用药学,2013,30(4):419-421. |
| LI Junrong,YE Mingli,ZENG Xueling,ZHONG Naifei.Determination of Fumaric Acid in Pharmaceutical Intermediate by Ion Chromatography[J].Chin J Mod Appl Pharm(中国现代应用药学),2013,30(4):419-421. |
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| 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。 |
| 关键词: 富马酸 医药中间体 离子色谱 电导检测 |
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| Determination of Fumaric Acid in Pharmaceutical Intermediate by Ion Chromatography |
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LI Junrong1, YE Mingli2, ZENG Xueling2, ZHONG Naifei2
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1.Wenling Hospital of Traditional Chinese Medicine, Taizhou 317500, China;2.Shanghai Laboratory of Application and Research Center, ThermoFisher China Limited, Shanghai 210013, China
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| 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. |
| Key words: fumaric acid pharmaceutical intermediate ion chromatography conductivity detection |
