【摘要】：建立了用于琥珀酸去甲文拉法辛中琥珀酸含量測定的高效離子抑制色譜和高效離子交換色譜方法。離子抑制色譜法采用Rezex ROA-organic Acid H+(8%)色譜柱,以2.50×10-3mol/L硫酸溶液為流動相等度洗脫,流速為0.5 mL/min,進樣10μL,檢測波長為210 nm,琥珀酸的含量按峰面積外標法計算;離子交換色譜法采用IonPac湟AS11-HC色譜柱,以氫氧化鉀為淋洗液等度洗脫,流速為1.0 mL/min,進樣10μL,帶DIONEX AERS湟500 4-mm抑制器的電導檢測器檢測,琥珀酸含量按峰面積外標法計算。兩種方法對3批琥珀酸去甲文拉法辛中琥珀酸質(zhì)量分數(shù)的測定結(jié)果分別為:28.8%、28.9%、28.9%和28.2%、28.6%、28.6%。離子抑制色譜法和離子交換色譜法在琥珀酸去甲文拉法辛中琥珀酸的含量測定結(jié)果上沒有明顯不同,可根據(jù)實際情況選擇。
[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.
【作者單位】： 遼寧醫(yī)學院藥學院;中國醫(yī)學科學院醫(yī)藥生物技術(shù)研究所;
【基金】：科技部新藥創(chuàng)制重大專項平臺項目(2012ZX09301002-001-019) 遼寧醫(yī)學院橫向課題(LYHX2013001)~~
【分類號】：TQ460.72;O657.7

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