Nijenhuis Cynthia M, Rosing Hilde, Schellens Jan H M, Beijnen Jos H
Department of Pharmacy & Pharmacology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Bioanalysis. 2014;6(23):3215-24. doi: 10.4155/bio.14.171.
To further investigate the pharmacokinetics of vemurafenib and to support therapeutic drug monitoring an LC-MS/MS method was developed and validated for the quantification of vemurafenib in dried blood spots.
Vemurafenib was extracted from the dried blood spots by methanol:acetonitrile (50:50, v/v) and separated on a C18 column with gradient elution and analyzed with triple quadrupole mass spectrometry in positive ion mode. The validated calibration range is linear from 1 to 100 µg/ml. Intra- and inter-assay accuracies and precisions were within ±13.6% and ≤6.5%. The applicability of the assay was tested by analyzing dried blood spots samples of melanoma patients receiving vemurafenib.
This assay met all predefined validation criteria and is considered suitable to quantify vemurafenib in dried blood samples.
为进一步研究维莫非尼的药代动力学并支持治疗药物监测，开发并验证了一种用于定量干血斑中维莫非尼的液相色谱-串联质谱（LC-MS/MS）方法。
采用甲醇：乙腈（50:50，v/v）从干血斑中提取维莫非尼，在C18柱上进行梯度洗脱分离，并用三重四极杆质谱在正离子模式下进行分析。验证后的校准范围为1至100μg/ml呈线性。批内和批间准确度和精密度在±13.6%以内和≤6.5%。通过分析接受维莫非尼治疗的黑色素瘤患者的干血斑样本对该检测方法的适用性进行了测试。
该检测方法符合所有预定义的验证标准，被认为适用于定量干血样本中的维莫非尼。
