期刊论文

中文

合成化学

1005-1511

2023

31

8

651-662

10.15952/j.cnki.cjsc.1005-1511.22108

2022JJ80096:湖南省自然科学基金项目 20A435:湖南省教育厅重点项目

本校为第一机构

阿伐那非作为高选择性的5型磷酸二酯酶抑制剂，是治疗勃起功能障碍的有效药物。阿伐那非易受环境影响，在酸碱性、氧化、光热条件下发生降解产生降解物，在生产工艺过程中存在副反应且产生有机杂质。为了保证药物的安全有效性，必须将有关物质控制在限度范围内，同时建立针对性检测方法以测定阿伐那非含量及鉴定有关物质。HPLC法以及基于QbD的HPLC法可用于准确检测阿伐那非的含量；液相和其他技术联用的LCMS-IT-TOF、 LC-MS/MS、 LC-QQQ-MS等方法能在测定其含量的同时鉴定物质结构。

As a highly selective PDE5 inhibitor,avanafil is an effective drug in the treatment of erectile dysfunction.There are organic impurities in the process of producing avanafil because of side reactions.Avanafil is easily affected by the environment and will degrade under ...MORE As a highly selective PDE5 inhibitor,avanafil is an effective drug in the treatment of erectile dysfunction.There are organic impurities in the process of producing avanafil because of side reactions.Avanafil is easily affected by the environment and will degrade under acid,alkaline,oxidation and photothermal conditions....