Pan Jiongwei, Jiang Xiangyu, Chen Yu-Luan
Charles River Laboratories, 334 South Street, Shrewsbury, MA 01545, USA.
Covance Laboratories, 3301 Kinsman Boulevard, Madison, WI 53704, USA.
Pharmaceutics. 2010 Apr 1;2(2):105-118. doi: 10.3390/pharmaceutics2020105.
A novel bioanalytical method was developed and validated for the quantitative determination of erlotinib in human plasma by using the supported liquid extraction (SLE) sample cleanup coupled with hydrophilic interaction liquid chromatography and tandem mass spectrometric detection (HILIC-MS/MS). The SLE extract could be directly injected into the HILIC-MS/MS system for analysis without the solvent evaporation and reconstitution steps. Therefore, the method is simple and rapid. In the present method, erlotinib- was used as the internal standard. The SLE extraction recovery was 101.3%. The validated linear curve range was 2 to 2,000 ng/mL based on a sample volume of 0.100-mL, with a linear correlation coefficient of > 0.999. The validation results demonstrated that the present method gave a satisfactory precision and accuracy: intra-day CV < 5.9% (.
开发并验证了一种新型生物分析方法，用于通过支持液液萃取（SLE）样品净化结合亲水相互作用液相色谱和串联质谱检测（HILIC-MS/MS）定量测定人血浆中的厄洛替尼。SLE提取物可直接注入HILIC-MS/MS系统进行分析，无需溶剂蒸发和复溶步骤。因此，该方法简单快速。在本方法中，使用厄洛替尼作为内标。SLE萃取回收率为101.3%。基于0.100-mL的样品体积，验证的线性曲线范围为2至2000 ng/mL，线性相关系数>0.999。验证结果表明，本方法具有令人满意的精密度和准确度：日内CV<5.9%（。
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