發(fā)布時(shí)間：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測(cè)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(dòng)相等度洗脫,流速為0.5 mL/min,進(jìn)樣10μL,檢測(cè)波長(zhǎng)為210 nm,琥珀酸的含量按峰面積外標(biāo)法計(jì)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(jìn)樣10μL,帶DIONEX AERS湟500 4-mm抑制器的電導(dǎo)檢測(cè)器檢測(cè),琥珀酸含量按峰面積外標(biāo)法計(jì)算。兩種方法對(duì)3批琥珀酸去甲文拉法辛中琥珀酸質(zhì)量分?jǐn)?shù)的測(cè)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(cè)定結(jié)果上沒(méi)有明顯不同,可根據(jù)實(shí)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(xué)院藥學(xué)院;中國(guó)醫(yī)學(xué)科學(xué)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(zhuān)項(xiàng)平臺(tái)項(xiàng)目(2012ZX09301002-001-019) 遼寧醫(yī)學(xué)院橫向課題(LYHX2013001)~~
【分類(lèi)號(hào)】：TQ460.72;O657.7

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