Strategies in developing high-throughput liquid chromatography protocols for method qualification of pharmacopeial monographs

Glenn A. Kresge, Sylvia Grosse, Alexis Zimmer, Kaitlin M. Grinias, Mauro De Pra, Jenny Marie T. Wong, Frank Steiner, James P. Grinias

    Research output: Contribution to journalArticlepeer-review

    Abstract

    Method qualification is a key step in the development of routine analytical monitoring of pharmaceutical products. However, when relying on published monographs that describe longer method times based on older high-performance liquid chromatography column and instrument technology, this can delay the overall analysis process for generated drug products. In this study, high-throughput ultrahigh pressure liquid chromatography techniques were implemented to decrease the amount of time needed to complete a 24-run sequence to identify linearity, recovery, and repeatability for both drug assay and impurity analysis in 16 min. Multiple experimental parameters were tested to identify a range of experimental settings that could be used for the sequence while still maintaining this fast analysis time. The full sequence was replicated on a different system and with different columns, further demonstrating its robustness.

    Original languageEnglish (US)
    Pages (from-to)2964-2970
    Number of pages7
    JournalJournal of Separation Science
    Volume43
    Issue number15
    DOIs
    StatePublished - Aug 1 2020

    All Science Journal Classification (ASJC) codes

    • Analytical Chemistry
    • Filtration and Separation

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