In this application, a generic UPLC method was used to assess degradant peaks during a stress testing analysis of glimepiride drug substance.
The generic method demonstrated linearity over a large range of concentration as automatically calculated by Empower 2 CDS. The calibration curve was used to establish the kinetic behavior of glimepiride when subjected to the various stress conditions. Using single quadrupole MS spectral data assisted in the evaluation of peak purity of each major peak of interest.
This stability information will help to determine the appropriate diluents, method conditions, matrix options, standard and/or sample preparation for future experiments and will prove useful in the final method development of the drug product. The use of ACQUITY UPLC coupled to the SQ Detector and data analysis within Empower 2 decreased analysis time and enabled a workflow that proved to be more efficient than the traditional manual – and sometimes less information-rich – approaches that are used today.