Session 2: Considerations for Method Adjustment Across UHPLC and HPLC Systems

Strategies to Reduce Risk When Performing LC Method Adjustments

As laboratories face evolving materials, instrumentation, and regulatory expectations, understanding the circumstances that justify changing methods is essential. This is especially relevant as more methods are developed on higher performing UHPLC instruments and high-efficiency, sub-2-µm particle columns. These UHPLC methods are suitable for many systems, however, method adjustment may be needed to perform the analysis on HPLC systems. While there are guidelines for performing method adjustments, additional factors, including instrumentation, can impact the performance of the scaled method.

This three-part webinar series on analytical method adjustment in pharmaceutical analysis is designed to provide practical insights into when and how to adapt validated analytical methods.

Topics include:

• How to assess risk when performing method adjustments and identify some control strategies for more common method and instrument contributors
• How to adapt an analytical method, focusing on the impact of LC instrument characteristics and their impact on scaling from UHPLC to HPLC Columns
• Practical tips and strategies to consider when adjusting LC methods across a variety of instruments

This series is ideal for analysts, QA professionals, and method developers seeking actionable guidance rooted in real-world lab experience.

Session 2: Considerations for Method Adjustment Across UHPLC and HPLC Systems

This session will explore a real-world example of method adjustment, with a focus on scaling from UHPLC to HPLC, with appropriate instrumentation. We will review the key principles of scaling a method, including column selection and geometric scaling calculations. The impact of a wide range of instrument characteristics will also be demonstrated, including but not limited to delay volume and extra-column dispersion. Assessment of the scaled method will focus on meeting method suitability criteria when adjusting methods across equipment platforms.

Presenter: Andrew Steere (Evaluation Scientist II, Waters Corporation)

Andrew Steere is an Evaluation Scientist II at Waters Corporation. He works in the Validation and Competitive Analysis Group within the LC-MS business unit. He graduated from Marist College in 2018 with a degree in Chemistry. Prior to starting at Waters in 2021, he worked in a CRO and primarily focused on LC-TUV/MS and GC-FID/MS instrumentation in cGMP and R&D environments. His current work focuses on evaluating the performance of LC instrumentation across the market through application development and testing.