Unlocking Smoother HPLC Method Transfer
High-performance liquid chromatography (HPLC) is one of the mainstay techniques in an analytical chemistry lab. However, a key challenge in highly regulated laboratories is when scientists must switch from one HPLC system to another, or exchange methods between different labs and sites. The process of transferring a method to the receiving HPLC system involves checking and adjusting multiple parameters such as instrument settings and configurations. If this is not carried out carefully, the receiving instrument and method might produce results inconsistent with the original system in terms of retention times and peak shapes for the analytes of interest, ultimately rendering analysis unreliable. Conversely, making method adjustments can lead to lack of compliance with regulator validated analytical protocols. In this article, we review the main challenges with method transfer and highlight how advanced HPLC technologies can help smooth this transition.
The growing need for method transfer
There are a few scenarios where analytical procedures might need to be transferred between HPLC instruments:
1) Method transfer to new equipment in the same lab, perhaps to a different vendor or a newer iteration of your existing instrument.
2) Method transfer to equipment in a different lab, for example from an R&D laboratory to a QC laboratory, or from a sponsor laboratory to a contract research organization.
This second scenario is becoming more common because of increased outsourcing to external laboratories, and because methods are more frequently shared across multiple international sites within an organization. In many such cases, chromatography instruments are not identical, and so difficulties arise when scientists attempt to reproduce their results.
All HPLC protocols must also comply with the standardized guidelines for analytical chromatography created by regulatory bodies such as the World Health Organization, the United States Pharmacopeia (USP621 regulations), and the EU Good Manufacturing Practice guidelines. This presents challenges for scientists trying to adjust variables to an extent permitted by regulators while ensuring accurate and reproducible analysis.
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