表皮生长因子受体酪氨酸激酶抑制剂厄洛替尼（OSI-774）的液相色谱测定法
Liquid-chromatographic determination of erlotinib (OSI-774), an epidermal growth factor receptor tyrosine kinase inhibitor.
作者信息
Lepper Erin R, Swain Sandra M, Tan Antoinette R, Figg William D, Sparreboom Alex
机构信息
Clinical Pharmacology Research Core, Medical Oncology Clinical Research Unit, and Cancer Therapeutics Branch, National Cancer Institute, 9000 Rockville Pike, Building 10, Room 5A01, Bethesda, MD 20892, USA.
出版信息
J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Oct 25;796(1):181-8. doi: 10.1016/j.jchromb.2003.08.015.
A high-performance liquid-chromatographic (HPLC) assay with UV detection has been developed for the quantitative determination of erlotinib (OSI-774) in human plasma. Quantitative extraction was achieved by a single-solvent extraction involving a mixture of acetonitrile and n-butyl chloride (1:4, v/v). Erlotinib and the internal standard hydrochloride salt (OSI-597) were separated on a column packed with Nova-Pak C18 material and a mobile phase composed of acetonitrile and water, pH 2.0 (60:40, v/v). The column effluent was monitored with dual UV detection at wavelengths of 348 nm (erlotinib) and 383 nm (OSI-597). The calibration graph was linear in the range of 100-4500 ng/ml, with values for accuracy and precision ranging from 87.9 to 96.2% and 2.13 to 5.10%, respectively, for three different sets of quality control samples. The developed method was successfully applied to study the pharmacokinetics of erlotinib in a cancer patient at the recommended daily dose of 150 mg.
已开发出一种带紫外检测的高效液相色谱（HPLC）分析法，用于定量测定人血浆中的厄洛替尼（OSI - 774）。通过涉及乙腈和正丁基氯（1:4，v/v）混合物的单溶剂萃取实现定量萃取。厄洛替尼和内标盐酸盐（OSI - 597）在填充有Nova - Pak C18材料的柱上分离，流动相由乙腈和水组成，pH 2.0（60:40，v/v）。在348 nm（厄洛替尼）和383 nm（OSI - 597）波长下用双紫外检测监测柱流出物。校准曲线在100 - 4500 ng/ml范围内呈线性，对于三组不同的质量控制样品，准确度值范围为87.9%至96.2%，精密度值范围为2.13%至5.10%。所开发的方法成功应用于研究一名癌症患者在推荐日剂量150 mg下厄洛替尼的药代动力学。
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