Wednesday, June 26, 2013
11:00 AM EDT
Editors’ Series: A Generic HPLC-UV Platform Method for Cleaning Verification
We describe the development and qualification of a simple, 10-min generic HPLC-UV gradient method for quantitative assays of cleaning verification solutions (0.2 – 10 mg/mL) and demonstrate approaches to increase sensitivity to low ng/mL levels by large-volume injections, sample concentrations, and the use of long-path UV flow cells. We report the attainment of similar method performance with a run time of 1.5 min using sub-2-μm or sub-3-μm core–shell columns on ultrahigh-pressure LC (UHPLC) systems. We provide rationales for parameter selections during the method development process to illustrate how the application of modern chromatographic principles can be used to quickly optimize method performance for intended use. This generic analytical methodology is readily adaptable to rinse or swabbing solutions and potentially for other applications such as in-process (IPC) control testing or rapid potency assays of many pharmaceuticals.
Sponsored by: Shimadzu