ACQUITY Arc System: Transferring Validated HPLC Methods within USP Guidelines

Brian Murphy

Reading Time: 3 minutes

The thought of transferring established high performance liquid chromatography (HPLC) methods onto a another vendor’s LC, or a new platform like UHPLC/UPLC, may cause a bit of anxiety for those that may be unaware of how easy it can be.

The reason that the topic of analytical method transfer induces so much angst is that for the transfer of an LC method to succeed, the method has to work as well on the new system it is being transferred to as it did on the original system it was developed on. Additionally, regulators want documented proof that the transfer was completed successfully by demonstrating competency and analytical verification of equivalence (at the very least), or a complete re-validation for the very risk verse. This isn’t always perceived as a straightforward process.

Here is where the ACQUITY® Arc System from Waters can help.

The ACQUITY Arc System, enabled by Arc Multi-Flow path™ technology, is designed to replicate established HPLC methods developed with 3.5 – 5 µm particle columns onto a state-of-the-art LC platform, while strictly adhering to the guidelines and regulations set forth in USP Chapter 621.

The ACQUITY Arc System's multi-flow path helps analysts manage chromatographic conditions.
The ACQUITY Arc System’s multiple flow path technology helps analysts manage chromatographic dispersion.

How is this done? To transfer a method with the ACQUITY Arc System, the analyst chooses one of two flow paths that best replicates the results coming from their legacy HPLC systems. Dwell volume is selectable in the software making it easy to emulate both the dwell volume of the legacy system as well as its mobile phase mixing behavior, and enable the transfer of LC methods from any commercial LC system.

Then, there are the productivity improvements brought to the analytical laboratory by the ACQUITY Arc System. For example, it’s an accepted fact that LC methods developed by R&D, often on a UPLC instrument, commonly end up as HPLC methods by the time they reach the QC lab. Adjusting UPLC methods developed with smaller sub-2-µm particle columns to HPLC methods on larger 3.5 – 5 µm particle columns is one of the tasks the ACQUITY Arc System was intended for. Powered by Empower® Chromatography Data Software, the Arc System is the perfect choice for regulated and QC laboratories.

What’s more, if an analyst wants significantly better throughput and efficiency than they can get from their HPLC method, the system is perfectly suited to convert that method onto a 2.5 – 2.7 µm particle HPLC column. And by harnessing the power of Waters Auto-Blend Plus™ technology, which enables users to program mobile phase composition directly in units of pH and % organic, minimizing human error often observed with manual mobile phase manipulation.

With true plug-and-play method compatibility for HPLC and UHPLC separations, hundreds of laboratories have adopted the ACQUITY Arc System. Isn’t it time for you to upgrade your HPLC(s) as well?

To learn more, visit legacy-stage.waters.com/arc.

 

Method transfer examples:

 

Originally published in Pittcon Today, 3/7/2016