【摘要】 目的 :建立分离非那雄胺有关杂质的反相高效液相色谱法。方法 :以ODS柱 (2 5cm× 4 .6mm ,5 μm)为固定相 ,乙腈 0 .0 4mol/L磷酸 (用NaOH溶液调至pH =4 .0 ) (5 5 :4 5 )为流动相 ,2 15nm为检测波长 ,分离非那雄胺有关杂质及中间体 ,酸、碱、过氧化氢强烈破坏产物。结果 :非那雄胺有关杂质及合成中间体 ,酸、碱、过氧化氢强烈破坏产物分离良好。结论 :本方法专属性强 ,灵敏度高。可用于检查非那雄胺有关杂质更多还原

【Abstract】 OBJECTIVE:A RP HPLC method was established for the separation of finasteride and related impurities. METHOD:Chromatographic column: ODS column(250×4.6mm,5μm); mobile phase: acetonitrile 0.04mol/L phosphovic acid(adjust to pH=4.0 with sodium hydroxide)(55:45,v/v); flow rate:1.0ml/min; wavelength of UV detector: 215nm. The impurities in finasteride and intermediate products and the products of violent ruin by acid, alkali, hydrogen peroxide respectively were separated.RESULTS:All the impurities and the products was base line separated with finasteride. CONCLUSION:This paper provides a specific and sensitive method for detection of impurities in fonasteride.更多还原