Division of Clinical Pharmacology and Therapeutics, The Children's Hospital of Philadelphia, USA.
J Chromatogr B Analyt Technol Biomed Life Sci. 2010 Sep 1;878(25):2369-73. doi: 10.1016/j.jchromb.2010.06.037. Epub 2010 Jul 3.
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.
我们描述了一种选择性和高灵敏度的高效液相色谱-电喷雾电离-碰撞诱导解离-串联质谱（HPLC-ESI-CID-MS/MS）分析方法，用于人血浆中的 Aurora A 激酶抑制剂 MLN8237。基于质量控制样品重复的标准偏差的日内精密度范围为 0.2%至 4%，准确度范围为 96%至 102%。日间精密度范围为 0.5%至 7%，准确度范围为 93%至 105%。稳定性研究表明，MLN8237 在样品制备和储存的预期条件下均稳定。MLN8237 的定量下限为 5ng/mL。该分析方法具有出色的灵敏度、精密度和准确度。该方法稳健，成功应用于儿童肿瘤学组（COG）一项关于 MLN8237 在癌症儿童中的 1 期联合研究。
