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Article
Strategies in developing high-throughput liquid chromatography protocols for method qualification of pharmacopeial monographs.
Journal of Separation Science (2020)
  • Glenn A. Kresge, Rowan University
  • Sylvia Grosse, Thermo Fisher Scientific
  • Alexis Zimmer, Rowan University
  • Kaitlin M. Grinias, GlaxoSmithKline
  • Mauro De Pra, Thermo Fisher Scientific
  • Jenny Marie T. Wong, Thermo Fisher Scientific
  • Frank Steiner, Thermo Fisher Scientific
  • James P. Grinias, Rowan University
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.
Publication Date
May 10, 2020
DOI
10.1002/JSSC.202000403
Citation Information
Glenn A. Kresge, Sylvia Grosse, Alexis Zimmer, Kaitlin M. Grinias, et al.. "Strategies in developing high-throughput liquid chromatography protocols for method qualification of pharmacopeial monographs." Journal of Separation Science Vol. 43 Iss. 15 (2020) p. 2964 - 2970
Available at: http://works.bepress.com/james-grinias/15/