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

• Published in: Journal of separation science Vol. 43; no. 15; pp. 2964 - 2970
• Main Authors: Kresge, Glenn A., Grosse, Sylvia, Zimmer, Alexis, Grinias, Kaitlin M., De Pra, Mauro, Wong, Jenny‐Marie T., Steiner, Frank, Grinias, James P.
• Format: Journal Article
• Language: English
• Published: Germany Wiley Subscription Services, Inc 01.08.2020
• Subjects: Chromatography; Column chromatography; high‐throughput analysis; Linearity; Liquid chromatography; method development; Parameter identification; pharmaceuticals; superficially porous particles; ultrahigh pressure liquid chromatography; method development; ultrahigh pressure liquid chromatography; high-throughput analysis; pharmaceuticals; superficially porous particles
• ISSN: 1615-9306; 1615-9314
• DOI: 10.1002/jssc.202000403

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.