Ternary Gradient for Tenofovir Disoproxil Fumarate Impurity Profiling

Instrument Type: UHPLC

The antiretroviral drug tenofovir is in formulation given as the prodrug tenofovir disoproxil fumarate (TDF) in combination with the nucleoside reverse-transcriptase inhibitor emtricitabine. Here we show the impurity profiling of an active pharmaceutical ingredient with the Thermo Scientfic Vanquish Flex UHPLC system. The simultaneous separation of early-eluting polar compounds and later-eluting nonpolar compounds is achieved by applying a ternary gradient with the quaternary Vanquish F pump using a Thermo Scientific Accucore aQ column.

Fast Nevirapine Impurity Profiling Using UHPLC-DAD

Instrument Type: UHPLC

This application describes an optimized method for the impurity profiling of nevirapine using a ballistic gradient method.The separation is completed in 2.8 min, compared to 80 min of the isocratic USP method. The Vanquish UHPLC system easily enables the simultaneous detection of the API and related impurities while achieving compliance with the ICH guidelines on impurity monitoring.