去甲文拉法辛有关物质的HPLC法测定  

Determination of Related Substances in O-Desmethylvenlafaxine by HPLC

作　　者：尚伟定 石晓伟[1] 马良[1] 薛娜[2] 张恺[1] 

机构地区：[1]河北医科大学药学院,河北石家庄050017 [2]河北化工医药职业技术学院,河北石家庄050026

出　　处：《中国医药工业杂志》2016年第5期607-610,共4页Chinese Journal of Pharmaceuticals

基　　金：河北省教育厅青年基金项目(Q2012028);河北省食品药品监督管理局科技计划项目(ZD2015022)

摘　　要：建立了高效液相色谱法测定去甲文拉法辛的有关物质。采用C8色谱柱,以25 mmol/L磷酸二氢铵缓冲液（含5 mmol/L庚烷磺酸钠,用磷酸调至p H 3.0）∶乙腈（75∶25）为流动相,检测波长224 nm。去甲文拉法辛及其3个有关物质均在0.5~2.0μg/ml范围内线性关系良好,检测限分别为0.14、0.20、0.20和0.10μg/ml,主要有关物质和破坏性试验产生的降解产物与去甲文拉法辛均能有效分离。An HPLC method was established for the determination of the related substances in O-desmethyl- venlafaxine. A C8 column was used with the mobile phase of 25 mmol/L ammonium dihydrogen phosphate solution （containing 5 mmol/L sodium 1-heptane sulphonate, adjusted to pH 3.0 with phosphoric acid） ： acetonitrile （75 ： 25） at the detection wavelength of 224 nm. It was linear for O-desmethylvenlafaxine and its three related substances in the range of 0.5-2.0 μg/ml. Their limits of detection were 0.14, 0.20, 0.20 and 0.10 μg/ml, respectively. The key impurities and degradation products generated in stress experiments could be separated effectively from O-desmethylvenlafaxine.

关 键 词：去甲文拉法辛 有关物质 高效液相色谱 测定 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]