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 16min. 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.
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