摘要
目的建立测定5-(2-氟苯基)-1H-吡咯-3-甲醛(TAK06)有关物质的高效液相色谱法(HPLC)。方法色谱条件为辛基硅烷键合相硅胶为填充剂的色谱柱,流动相A为0.1%的甲酸水溶液;流动相B为乙腈,并进行梯度洗脱。检测波长254 nm,流速1.0 m L/min。结果 5-(2-氟苯基)-1H-吡咯-3-甲醛(TAK06)与杂质A、杂质B、杂质C均能实现分离。结论本法简便、灵敏、专属性强,可用于5-(2-氟苯基)-1H-吡咯-3-甲醛(TAK06)有关物质的测定。
Objective TO establish a HPLC Method For the determination of Related Substance of 5-(2-fluorophenyl)-1H-pyrrole-3-carbaldehyde(TAK06). Methods The separation was performed on a C8 column, and the mobile phase A was 0.1% formic acid aqueous solution; Mobile phase B was acetonitrile and gradient elution.The detection wavelength was 254 nm, and the flow rate was 1.0ml/min. Results. 5-(2-fluorophenyl)-1H-pyrrole-3-carbaldehyde(TAK06) and impurities-A、impurities-B、 impurities-C was achieve separation. Conclusion This method is simple, sensitive and specific. It is suitable for the determination of Related Substance of 5-(2-fluorophenyl)-1H-pyrrole-3-carbaldehyde(TAK06).
