| Autor: |
Field, Jennifer K., Bruce, James, Buckenmaier, Stephan, Ming Yui Cheung, Euerby, Melvin R., Haselmann, Kim F., Lau, Jesper F., Stoll, Dwight, Sylvester, Maria, Thøgersen, Henning, Petersson, Patrik |
| Předmět: |
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| Zdroj: |
LC-GC Europe; Nov/Dec2022, Vol. 35 Issue 10, p440-449, 10p |
| Abstrakt: |
This review article summarizes the results obtained from the combined efforts of a joint academic and industrial initiative to solve the real-life challenge of determining low levels of peptide-related impurities (typically 0.05-1% of the drug substance) in the presence of the related biologically active peptide at a high concentration. A rational screening strategy for pharmaceutically important peptides has been developed that uses combinations of reversed-phase ultrahigh-pressure liquid chromatography (UHPLC) columns and mobile phases that exhibit complementary reversed-phase chromatographic selectivity using either UV- or mass spectrometry (MS)-compatible conditions. Numerous stationary and mobile phases were categorized using the chemometric tool of principal component analysis (PCA), employing a novel characterization protocol utilizing specifically designed peptide probes. This was successfully applied to the development of a strategy for the detection of impurities (especially isomers) in peptide drug substances using two-dimensional liquid chromatography coupled with MS detection (2D-LC-MS). [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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