一种用于测定人血浆中拉帕替尼和厄洛替尼的简易高效液相色谱法。
A Simple High-Performance Liquid Chromatography for Determining Lapatinib and Erlotinib in Human Plasma.
作者信息
Ohgami Masahiro, Homma Masato, Suzuki Yoshiharu, Naito Kanako, Yamada Motoko, Mitsuhashi Shoichi, Fujisawa Fumie, Kojima Hiroshi, Kaburagi Takayuki, Uchiumi Keiko, Yamada Yutaka, Bando Hiroko, Hara Hisato, Takei Keiji
机构信息
*Department of Pharmaceutical Sciences, Graduate School of Comprehensive Human Sciences, University of Tsukuba, Tsukuba, Japan; †Department of Pharmacy, Ibaraki Prefectural Central Hospital, Kasama, Japan; ‡Department of Pharmacy, University of Tsukuba Hospital, Tsukuba, Japan; §Department of Medical Oncology, Ibaraki Prefectural Central Hospital, Kasama, Japan; ¶Department of Respiratory Medicine, Ibaraki Prefectural Central Hospital, Kasama, Japan; and ‖Department of Breast and Endocrine Surgery, University of Tsukuba, Tsukuba, Japan.
出版信息
Ther Drug Monit. 2016 Dec;38(6):657-662. doi: 10.1097/FTD.00000000000003520.
BACKGROUND
Lapatinib and erlotinib are used for cancer treatment, showing large interindividual variability. Therapeutic drug monitoring may be useful for assessing the clinical outcomes and adverse events. A simple high-performance liquid chromatography UV method was developed for the determination of lapatinib and erlotinib in human plasma.
METHODS
An aliquot of plasma sample spiked with internal standard was treated with acetonitrile to precipitate the proteins. Lapatinib and erlotinib were separated on an octadecylsilyl silica gel column using a mobile phase consisting of acetonitrile, methanol, water, and trifluoroacetic acid (26:26:48:0.1) pumped at a flow rate of 1.0 mL/min. The detection wavelength was set at 316 nm.
RESULTS
The calibration curves for lapatinib and erlotinib were linear (r = 0.9999) in the range of 0.125-8.00 mcg/mL. The extraction recoveries for both lapatinib and erlotinib at the plasma concentration of 0.125-8.00 mcg/mL were higher than 89.9% with coefficients of variation less than 3.5%. The coefficients of variation for intraday and interday assays of lapatinib and erlotinib were less than 5.1% and 6.1%, respectively.
CONCLUSIONS
The present method can be used for blood concentration monitoring for lapatinib or erlotinib in exactly the same conditions.
背景
拉帕替尼和厄洛替尼用于癌症治疗，个体间差异较大。治疗药物监测可能有助于评估临床疗效和不良事件。开发了一种简单的高效液相色谱紫外法用于测定人血浆中的拉帕替尼和厄洛替尼。
方法
取一份加入内标的血浆样品等分试样，用乙腈处理以沉淀蛋白质。拉帕替尼和厄洛替尼在十八烷基硅烷硅胶柱上分离，流动相由乙腈、甲醇、水和三氟乙酸（26:26:48:0.1）组成，流速为1.0 mL/min。检测波长设定为316 nm。
结果
拉帕替尼和厄洛替尼的校准曲线在0.125 - 8.00 mcg/mL范围内呈线性（r = 0.9999）。拉帕替尼和厄洛替尼在血浆浓度为0.125 - 8.00 mcg/mL时的提取回收率均高于89.9%，变异系数小于3.5%。拉帕替尼和厄洛替尼日内和日间测定的变异系数分别小于5.1%和6.1%。
结论
本方法可在完全相同的条件下用于拉帕替尼或厄洛替尼的血药浓度监测。
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