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Strategies in developing high‐throughput liquid chromatography protocols for method qualification of pharmacopeial monographs
Author(s) -
Kresge Glenn A.,
Grosse Sylvia,
Zimmer Alexis,
Grinias Kaitlin M.,
De Pra Mauro,
Wong JennyMarie T.,
Steiner Frank,
Grinias James P.
Publication year - 2020
Publication title -
journal of separation science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.72
H-Index - 102
eISSN - 1615-9314
pISSN - 1615-9306
DOI - 10.1002/jssc.202000403
Subject(s) - repeatability , chromatography , throughput , robustness (evolution) , computer science , high performance liquid chromatography , linearity , process engineering , chemistry , engineering , telecommunications , biochemistry , wireless , gene , electrical engineering
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.