Editors' Series: A Generic HPLC-UV Platform Method for Cleaning Verification - - Chromatography Online
Editors' Series: A Generic HPLC-UV Platform Method for Cleaning Verification

Wednesday, June 26, 2013

11:00 AM EDT

Editors’ Series: A Generic HPLC-UV Platform Method for Cleaning Verification

Register Free >>

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


blog comments powered by Disqus
LCGC E-mail Newsletters
Global E-newsletters subscribe here:



Column Watch: Ron Majors, established authority on new column technologies, keeps readers up-to-date with new sample preparation trends in all branches of chromatography and reviews developments. LATEST: When Bad Things Happen to Good Food: Applications of HPLC to Detect Food Adulteration

Perspectives in Modern HPLC: Michael W. Dong is a senior scientist in Small Molecule Drug Discovery at Genentech in South San Francisco, California. He is responsible for new technologies, automation, and supporting late-stage research projects in small molecule analytical chemistry and QC of small molecule pharmaceutical sciences. LATEST: HPLC for Characterization and Quality Control of Therapeutic Monoclonal Antibodies

MS — The Practical Art: Kate Yu brings her expertise in the field of mass spectrometry and hyphenated techniques to the pages of LCGC. In this column she examines the mass spectrometric side of coupled liquid and gas-phase systems. Troubleshooting-style articles provide readers with invaluable advice for getting the most from their mass spectrometers. LATEST: Radical Mass Spectrometry as a New Frontier for Bioanalysis

LC Troubleshooting: LC Troubleshooting sets about making HPLC methods easier to master. By covering the basics of liquid chromatography separations and instrumentation, John Dolan is able to highlight common problems and provide remedies for them. LATEST: How Much Can I Inject? Part I: Injecting in Mobile Phase

More LCGC Columnists>>

LCGC North America Editorial Advisory Board>>

LCGC Europe Editorial Advisory Board>>

LCGC Editorial Team Contacts>>

Click here