Department of Drug Metabolism & Pharmacokinetics, Genentech Inc., South San Francisco, CA, USA.
Department of Bioanalytical Chemistry, Labcorp Early Drug Development, Madison, WI, USA.
Bioanalysis. 2022 Nov;14(21):1377-1389. doi: 10.4155/bio-2022-0189. Epub 2023 Jan 19.
Volumetric absorption microsampling devices offer minimally invasive and user-friendly collection of capillary blood in volumes as low as 10 μl. Herein we describe the assay validation for determination of the selective estrogen receptor degrader giredestrant (GDC-9545) in dried human whole blood collected using the Mitra and Tasso-M20 devices. Both LC-MS/MS assays met validation acceptance criteria for the linear range 1-1000 ng/ml giredestrant. Mitra and Tasso-M20 samples were stable for 84 and 28 days at ambient conditions, respectively, and for 7-9 days at 40 and -70°C. Blood hematocrit, hyperlipidemia and anticoagulant did not impact quantitation of giredestrant. These validated assays are suitable for the determination of giredestrant in dried blood samples collected using Mitra and Tasso-M20 microsampling devices.
体积吸收微采样装置可微创且用户友好地采集低至 10μl 的毛细血管全血。本文介绍了使用 Mitra 和 Tasso-M20 装置采集的干燥人全血中选择性雌激素受体降解剂 giredestrant（GDC-9545）的测定验证。两种 LC-MS/MS 测定方法均满足线性范围 1-1000ng/ml giredestrant 的验证接受标准。Mitra 和 Tasso-M20 样本在环境条件下分别稳定 84 天和 28 天，在 40°C 和-70°C 下分别稳定 7-9 天。血液血细胞比容、高血脂症和抗凝剂不会影响 giredestrant 的定量。这些经过验证的测定方法适用于使用 Mitra 和 Tasso-M20 微采样装置采集的干燥血样中 giredestrant 的测定。
