Application of an automated multi-pH and multi-temperature platform for accelerated solution stability testing in supporting drug discovery

Abstract

An automated method for testing the solution stability of drug discovery candidates is described. The method simultaneously tests a compound's stability over 20 h at two temperatures (37 °C and 60 °C) and at as many as six pH values ranging from pH 1 to pH 10. Stability kinetics for each pH and temperature combination are monitored at ∼2 h intervals. Automated liquid handling was used for the sample collection and preparation. Sample analysis was streamlined using an HPLC autosampler and data analysis was automated via proprietary data handling and archival software (AstraZeneca). Scientific validation of the method and application to support drug discovery is also illustrated.