高效离子抑制色谱法和高效离子交换色谱法检测琥珀酸去甲文拉法辛中琥珀酸的含量

发布时间：2019-07-19 10:18

【摘要】：建立了用于琥珀酸去甲文拉法辛中琥珀酸含量测定的高效离子抑制色谱和高效离子交换色谱方法。离子抑制色谱法采用Rezex ROA-organic Acid H+(8%)色谱柱,以2.50×10-3mol/L硫酸溶液为流动相等度洗脱,流速为0.5 mL/min,进样10μL,检测波长为210 nm,琥珀酸的含量按峰面积外标法计算;离子交换色谱法采用IonPac湟AS11-HC色谱柱,以氢氧化钾为淋洗液等度洗脱,流速为1.0 mL/min,进样10μL,带DIONEX AERS湟500 4-mm抑制器的电导检测器检测,琥珀酸含量按峰面积外标法计算。两种方法对3批琥珀酸去甲文拉法辛中琥珀酸质量分数的测定结果分别为:28.8%、28.9%、28.9%和28.2%、28.6%、28.6%。离子抑制色谱法和离子交换色谱法在琥珀酸去甲文拉法辛中琥珀酸的含量测定结果上没有明显不同,可根据实际情况选择。
[Abstract]:A high performance ion inhibition chromatography and a high performance ion exchange chromatography method for the determination of succinic acid in succinic acid norvenlafaxine were established. Rezex ROA-organic Acid H (8%) column was used for ion suppression chromatography, 2.50 脳 10-3mol/L sulfuric acid solution was used as mobile phase eluting, the flow rate was 0.5 mL/min, 10 渭 L, and the detection wavelength was 210 nm, succinic acid. The content of succinic acid was calculated according to the external standard method of peak area. IonPac Huang AS11-HC column was used for ion exchange chromatography, potassium hydroxide was used as eluent, the flow rate was 1.0 mL/min, 10 渭 L, and the content of succinic acid was determined by conductivity detector with DIONEX AERS Huang 500 4-mm suppression. the content of succinic acid was calculated according to the external standard method of peak area. The mass fraction of succinic acid in three batches of norvenlafaxine succinate was 28.8%, 28.9%, 28.9% and 28.2%, 28.6% and 28.6%, respectively. There is no significant difference between ion inhibition chromatography and ion exchange chromatography in the determination of succinic acid in norvenlafaxine succinate, which can be selected according to the actual situation.
【作者单位】：辽宁医学院药学院;中国医学科学院医药生物技术研究所;
【基金】：科技部新药创制重大专项平台项目(2012ZX09301002-001-019) 辽宁医学院横向课题(LYHX2013001)~~
【分类号】：TQ460.72;O657.7

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