How Transferring Validated HPLC Methods Within USP Guidelines Works

Problem: The topic of technology transfer raises caution with many laboratory managers of analytical laboratories. In routine analysis laboratories, such as QA/QC, the need for continued support of established high performance liquid chromatography (HPLC) methods can significantly outweigh the potential advantages of method modernization, making it exceptionally problematic or undesirable to adopt more modern liquid chromatography (LC) assays or instrumentation such as U(H)PLC ultra-high performance LC.

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Simply select between HPLC mode and UHPLC mode with Arc Multi-flow Path Technology.

 

One of the key issues with transferring methods is the ability to replicate the result from one type of LC system to another. This is particularly challenging for gradient methods which requires the user to match not only the dwell volume of the system, but also the profile (or behavior) in which mobile phases are mixed. In addition, the ability to modernize these assays has been limited due to guidance described by the United States Pharmacopeia (USP), specifically outlined in Chapter 621 where making changes to the gradient methods are perceived as being risky and poorly understood.


Solution: Although the USP discourages making changes to gradient methods, guidance does allow for adjustments to be made to a validated HPLC method if necessary. As stated within USP Chapter , “If adjustments are necessary, change in…the duration of an initial isocratic hold (when prescribed), and/or dwell volume adjustments are allowed.” The ACQUITY Arc System was specifically designed to facilitate efficient technology transfer while strictly adhering to these method adjustment guidelines and regulations.

The ACQUITY Arc System, with Arc Multi-flow Path Technology was designed specifically to enable analysts to successfully transfer their established HPLC methods onto a modern LC platform, while providing the flexibility to further improve productivity in the future. By simply selecting between one of two fluidic paths in the system software, the user can reproduce the results created on their legacy HPLC systems in efforts to transfer theirestablished HPLC methods from one LC platform to another. Alternatively, a second fluidic path can be selected to improve performance by pairing the system with more modern 2.x µm UHPLC columns. This novel technology essentially provides a selectable dwell volume to effortlessly enable the transfer of LC methods from any commercial LC system, mitigating the need to revalidate the assay by emulating both the dwell volume as well as behavior of which the mobile phases are mixed.

Having a choice of two fluidic paths provides a simple and easy way to emulate HPLC or UHPLC performance on a single LC system. It’s like having two LC systems in one! Significant productivity gains can now be realized by deploying a single LC platform that allows the efficient transfer, adjustment, or improvement of methods from any LC platform without compromise.

For more information, please visit www.waters.com/arc

Categories: How it Works

Published In

Regulatory Compliance Magazine Issue Cover
Regulatory Compliance

Published: March 11, 2016

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