High-throughput salting-out assisted liquid/liquid extraction and ultrafast LC for same-day delivery of first-in-human bioanalytical data

Background: With the need of fast-paced drug development, rapid delivery of bioanalytical data becomes a trend. Here, we present a strategy to demonstrate same-day data delivery. Results: A novel salting-out assisted liquid/liquid extraction (SALLE) with acetonitrile and a MS-friendly salt was used to extract analyte from the first-in-human study plasma samples and the extract was successfully injected into ultrafast chromatography. The strategic combination of SALLE and ultrafast chromatography minimizes the turnaround time and allows the same-day delivery of bioanalytical data. The time saving from both extraction and injection was translated to a fast delivery of bioanalytical data. Conclusion: The first-in-human pharmacokinetic data of an investigational new drug candidate was delivered in approximately 4.5 work h after receiving the samples of each dose group using high-throughput SALLE and ultrafast LC. Incurred sample reassay results proved uncompromised data quality with the high-speed bioanalysis.