This Application Note describes a method to analyze traces of potential genotoxic impurities (PGIs) in pharmaceuticals using the Agilent 1290 Infinity LC system and a 60 mm Agilent Max-Light Cartridge Cell, which offers maximum sensitivity.
The document details an analytical method developed by researchers at the Research Institute for Chromatography and Agilent Technologies to analyze traces of potential genotoxic impurities (PGIs) in pharmaceuticals. The study utilizes a generic method to separate ten specific arylamine and aminopyridine impurities using UHPLC coupled with a Diode-Array Detector (DAD).
To achieve the required low detection limits without mass spectrometry, the method employs an Agilent Max-Light Cartridge High Sensitivity Cell featuring a 60 mm optical path length. The note provides specific experimental procedures for sample preparation and lists detailed chromatographic conditions, including column types, mobile phases, gradients, and temperature settings for both generic and dedicated methods.
The cell has an optical path length of 60 mm with an internal volume of only 4 pL.
Detection limits were as low as 0.2 ng/mL, which corresponds to 4 pg on-column.
Analysis times are approximately 5 minutes when developed for a relevant combination of PGI and API.