Troubleshooting Peak Splitting in HILIC Method Migration

This technical report discusses the troubleshooting of peak splitting observed during the migration of the USP Cetirizine Hydrochloride Organic Impurities method to two different HPLC systems: the Alliance iS HPLC System and Vendor X HPLC System. The report outlines the challenges faced due to the unique characteristics of hydrophilic interaction liquid chromatography (HILIC) methods, particularly when migrating methods across systems with different designs. It details the investigative work performed to identify the root cause of the peak splitting, including the evaluation of needle wash compositions and their impact on chromatography. The study found that the needle wash mechanism significantly affected the results, with a high percentage of water in the wash leading to chromatographic issues. The report presents findings from various needle wash compositions and their effects on system suitability, emphasizing the importance of optimizing needle wash design for successful HILIC method migration.