February 26–March 1, 2007, PITTCON® 2007, Chicago, IL

Automating the Development of Liquid Chromatographic Methods for Impurity and Stability Samples Using High Sensitivity, High Resolution LC/MS

Michael Swartz, Michael Jones, Michael McBrien

Abstract

Samples generated in support of purity and stability studies can be very complex. Closely related substances, disparate levels, and unknown analytes often present at low levels (0.1 to 0.05% or less) provide significant challenges for method development. In addition, as selectivity is manipulated and elution orders change, these same challenges make it even more difficult to track or identify peaks in the final method. This situation is particularly troublesome when trying to automate method development. Methods must also be robust, especially in the case of long term stability studies, as they may be in use for long periods of time.

In this presentation, we will demonstrate a new way of completely automating the development of chromatographic methods for samples generated in support of purity and stability studies by employing new software algorithms and mass spectrometry (MS). Software tools will be described that fully automate column and method selection, while using MS to track and identify individual analytes, even at the low and/or disparate levels required. In addition, we will also illustrate a new way of developing methods from composite samples generated under multiple forced degradation conditions. Gains in sensitivity, resolution and separation speed made possible by the use of sub-two micron particle size column chemistries will also be reported. Using this system approach, high sensitivity, high resolution methods can be developed in a fraction of the time compared to traditional techniques.

Download the presentation in Adobe Acrobat format (636 Kb PDF file).

Relevant Products: ACD/Method Development Suite, ACD/MS Manager, ACD/IntelliXtract, AutoChrom for Empower

Relevant Solution: Method Development