ABSTRACT

A large proportion of pharmaceuticals are basic or alkaline organic compounds. The analysis of basic compounds has traditionally presented signi“cant challenges to reversed-phase (RP) HPLC due to severe peak tailing caused by secondary interactions between charged basic analytes and active residual silanols on RP stationary phases.1 The peak-tailing problem has been largely addressed in the 1990s with

15.1 Introduction .................................................................................................. 345 15.2 HILIC Method for Purity and Stability Monitoring of 4-AMP ................... 347

15.2.1 Method Development ........................................................................ 347 15.2.1.1 HILIC-Column Screening ................................................. 347 15.2.1.2 Mobile-Phase Components ................................................348 15.2.1.3 Column Temperature ......................................................... 356

15.2.2 Method Validation ............................................................................ 358 15.3 HILIC-CLND Method for Hydrazine Residues in an Intermediate ............360