使用UHPLC-DAD快速分析奈韦拉平杂质

　　Nevirapine is a non-nucleoside reverse transcriptase inhibitor with activity against human immunodeficiency virus type 1 (HIV-1), currently marketed for the treatment of HIV-1 infected adults.1 The United States Pharmacopeia (USP) uses a reversed-phase high-performance liquid chromatography (HPLC) separation with UV detection to determine nevirapine and its impurities. The related column is a 4.6 × 150 mm column packed with L60 (spherical, porous silica gel, 5 μm in diameter).2 Due to the strong retention of impurity C, the USP monograph method requires about 30 minutes to separate this API and known impurities. A previous Dionex, now part of Thermo Scientific, application note demonstrated that an HPLC-UV separation can meet or exceed the chromatographic requirements of the USP monograph method for nevirapine while requiring about half the analysis time per sample.