Establishment of Performance Qualification Criteria for HPLC Systems Dedicated to Peptide Mapping

Library Number:
Part Number:
Paul D. Rainville, Thomas E. Wheat, Richard W. Andrews, and Jeffery R. Mazzeo
WCBP, January 10th-13th, 2005
Content Type:
Content Subtype:
Waters MassPREP™ PQ Peptide Mixture; Waters MassPREP™ Peptide Mixture
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Appropriate qualification procedures for HPLC systems are basic requirements for the validation and use of analytical methods. Peptide mapping is a particularly important tool for the characterization of therapeutic proteins. Because this reversed phase HPLC technique is exceptionally sensitive to experimental variability, it is important to thoroughly characterize the system. A performance qualification test that best mimics peptide analysis is advantageous for predicting how the system will perform with real samples. We have established performance standards for reversed-phase HPLC in conjunction with both UV and MS detection for systems dedicated to running peptide maps. The criteria and specifications include retention time reproducibility, injector reproducibility and injector linearity. Mass accuracy was included for MS configurations. This qualification method includes the use of a well-characterized peptide analyte mix, a tested HPLC column specific for peptide analysis, and a detailed protocol. The developed procedure could also be used as a routine system suitability test.

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