A sensitive and selective liquid chromatography/tandem mass spectrometry method for determination of MLN8237 in human plasma |
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Authors: | Emily Lipsitz Ganesh Moorthy Yael Mosse Elizabeth Fox Peter C. Adamson |
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Affiliation: | 1. Division of Clinical Pharmacology and Therapeutics, The Children''s Hospital of Philadelphia, United States;2. Division of Oncology, The Children''s Hospital of Philadelphia, United States |
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Abstract: | We describe a selective and a highly sensitive high-performance liquid chromatography–electron spray ionization-collision induced dissociation-tandem mass spectrometry (HPLC–ESI-CID-MS/MS) assay for the Aurora A kinase inhibitor MLN8237 in human plasma. The intra-day precision based on the standard deviation of replicates of quality control samples ranged from 0.2 to 4% and with accuracy ranging from 96 to 102%. The inter-day precision ranged from 0.5 to 7% and the accuracy ranged from 93 to 105%. Stability studies showed that MLN8237 was stable both during the expected conditions for sample preparation and storage. The lower limit of quantification for MLN8237 was 5 ng/mL. The analytical method showed excellent sensitivity, precision, and accuracy. This method is robust and is being successfully employed in a Children's Oncology Group Phase 1 Consortium study of MLN8237 in children with cancer. |
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Keywords: | MLN8237 LC&ndash ESI-CID-MS/MS Plasma Pediatric Cancer |
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