Modernization of Liquid Chromatography Methods

Adoption of the revised USP <621> guidance for analytical method transfers and modernization of LC methods. Modernization of LC methods is key in lifecycle management of analytical procedures. United States Pharmacopeia (USP) General Chapter <621> allows method adjustments and transfers, making it easier for labs to modernize original USP methods. The revised version of USP <621>, which became effective in December 2022, has been updated to meet industry needs. The USP <621> revisions allow a change in gradient methods, as well as a change from totally porous silica based analytical columns to superficially porous particle-based columns. These changes were not permitted in previous versions. A few case studies for method transfers that depict method modernization will be presented in this webinar. Significant improvement in lab productivity and cost savings were achieved by modernizing original USP methods that use classic column technology to newer and smaller particle technology. Modernization of liquid chromatography (LC) methods is critical for lab productivity and sustainability as well as for keeping up to date with regulatory guidelines. This webinar features two expert speakers who will share insights into the latest LC methods and technologies. Rongjie Fu will cover how to modernize method transfers and adjustments based on revisions to the United States Pharmacopeia (USP), exploring how this can improve lab productivity. Dr. Monique Paré Speirs will then demonstrate how inefficient high-performance LC methods can be overhauled with updated technology to enhance lab sustainability without compromising method accuracy and precision. Conventional LC methodologies to analyze ingredients in consumer products are falling short of increasing industry demands. They are often limited by inefficient single-analyte test methods, LC-damaging mobile phases, and classic HPLC column technologies with high flow rates, long acquisition runs, and excess solvent waste. Considering the immense testing requirements of growing product industries, updates to regulatory guidelines, environmental sustainability initiatives, and ever-improving LC technology at our fingertips, there is no need to continue suffering through the challenges of outdated LC techniques. Any method compromising your column, instrument, and/or lab throughout is in serious need of a makeover! We demonstrate how this can be achieved via an “extreme makeover” whereby two inefficient, LC-destructive, single-analyte HPLC methods are combined into a single method using LC-friendly mobile phases and modernized column technology designed for faster HPLC or UHPLC separations. We walk through the major elements of a product-specific method validation to demonstrate the LC system and method are suitable for the intended use in the context of a representative OTC product. The principles covered can be applied to a broad range of method development and validation applications with the aim to enhance lab productivity and sustainability without compromising method accuracy and precision.