Fast Nevirapine Impurity Profiling Using UHPLC-DAD

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. The United States Pharmacopeia (USP) uses a reversed-phase HPLC separation with UV detection to determine nevirapine and its impurities. This application note reports optimization of this approach, using a state of the art gradient UHPLC-UV method. Applying ballistic gradients with latest-generation UHPLC equipment achieves significantly shorter analysis time while maintaining compliance with ICH requirements.