Method Migration of the USP Ibuprofen Assay and Organic Impurities Method to an Alliance™ iS HPLC System

Method migration, or moving a method from one high-performance liquid chromatography (HPLC) system to another, is routine practice in many regulated laboratories, where there may be a variety of HPLC systems from different vendors and different models in a single lab. However, moving a method across systems can be challenging as differences between instrument designs may lead to chromatographic changes that can impact critical results. Alternatively, lack of familiarity with proper set up or operation of a system can also lead to poor results and may be much harder for the end user to identify. The Alliance iS HPLC System aims to make method migration more straightforward with improved usability features that limit analyst error and improve system reliability while maintaining chromatographic and quantitative performance. In this study a United States Pharmacopeia (USP) monograph method for the analysis of Ibuprofen and related impurities is replicated on two legacy HPLC systems and subsequently migrated to the Alliance iS HPLC System. Results are analyzed and compared, with all three systems demonstrating comparable results while meeting the USP system suitability requirements.