*Platform of Oncology, Hospital Quirón, Torrevieja (Alicante); and †Pharmacokinetics and Drug Metabolism Department, AMGEN Inc, Valencia, Spain.
Ther Drug Monit. 2013 Dec;35(6):796-802. doi: 10.1097/FTD.0b013e3182959080.
A selective and precise high-performance liquid chromatography ultraviolet method was developed and validated for the determination of lapatinib in human plasma. After protein precipitation with acetonitrile, lapatinib and sorafenib were separated using isocratic elution (on a C18 Ultrabase column using a mobile phase of acetonitrile/20 mM ammonium acetate in a proportion 53:47 (v/v) pumped at a constant flow rate of 1.2 mL/min). Quantification was performed at 260 nm. Calibration curves were linear over the range 0.2-10 µg/mL. Inter- and intraday coefficients of variation were less than 7%. The limit of detection and the lower limit of quantification were 0.1 and 0.2 µg/mL, respectively. Recoveries of lapatinib from plasma were higher than 86.7% in all cases. The assay was applied to the determination of the drug in the plasma of 2 cancer patients receiving lapatinib, 1000 and 1250 mg orally, and could be useful for therapeutic drug monitoring of lapatinib in routine clinical practice.
建立并验证了一种选择性和精确的高效液相色谱紫外检测法，用于测定人血浆中的拉帕替尼。采用乙腈沉淀蛋白后，采用等度洗脱（于 C18 Ultrabase 柱上，以乙腈/20 mM 乙酸铵（53:47，v/v）为流动相，以 1.2 mL/min 的恒定流速泵入）分离拉帕替尼和索拉非尼。在 260nm 处进行定量分析。校准曲线在 0.2-10μg/mL 范围内呈线性。日内和日间变异系数均小于 7%。检测限和定量下限分别为 0.1 和 0.2μg/mL。拉帕替尼在所有情况下从血浆中的回收率均高于 86.7%。该测定法可用于测定 2 名接受拉帕替尼治疗的癌症患者的血浆中药物浓度，分别给予 1000mg 和 1250mg 口服，可用于常规临床实践中拉帕替尼的治疗药物监测。
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