A simple, sensitive, and specific liquid chromatography-tandem mass spectrophotometry (LC-MS/MS) method was developed and validated for the quantification of lenalidomide in human plasma. The separation was carried out on a symmetry, C18, 5-μm (50 × 4.6 mm) column as stationary phase and with an isocratic mobile phase of 0.1% formic acid in water-methanol in the ratio of (15:85, v/v) at a flow rate of 0.5 mL/min. Protonated ions formed by electrospray ionization in the positive mode were used to detect analyte and fluconazole (internal standard). The mass detection was made by monitoring the fragmentation of m/z 260.1/148.8 for lenalidomide and m/z 307.1/238.0 for internal standard on a triple quadrupole mass spectrometer. The developed method was validated over the concentration range of 10–1000 ng/mL for lenalidomide in human plasma with a correlation coefficient (r2) was 0.9930. The accuracy and precision values obtained from six different sets of quality control samples analyzed on separate occasions ranged from 99.41 to 106.97% and 2.88 to 4.22%, respectively. Mean extraction recoveries were 98.06% and 88.78% for the analyte and IS, respectively. The developed method was successfully applied for analyzing lenalidomide in human plasma samples.

中文翻译：

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液相色谱-串联质谱法测定人血浆中来那度胺的开发和验证及其在生物等效性研究中的应用

开发并验证了一种简单、灵敏且特异的液相色谱-串联质谱 (LC-MS/MS) 方法，用于定量人血浆中的来那度胺。分离在对称的 C18, 5-μm (50 × 4.6 mm) 色谱柱上进行，固定相为 0.1% 甲酸在水-甲醇中的等度流动相，比例为 (15:85, v/ v) 流速为 0.5 mL/min。在正模式下通过电喷雾电离形成的质子化离子用于检测分析物和氟康唑（内标）。通过在三重四极杆质谱仪上监测来那度胺的 m/z 260.1/148.8 和内标的 m/z 307.1/238.0 的碎片来进行质量检测。开发的方法在 10–1000 ng/mL 浓度范围内对人血浆中的来那度胺进行了验证，相关系数 (r2) 为 0.9930。从在不同场合分析的六组不同质量控制样品获得的准确度和精密度值分别介于 99.41 至 106.97% 和 2.88 至 4.22% 之间。分析物和内标的平均提取回收率分别为 98.06% 和 88.78%。所开发的方法已成功应用于分析人血浆样品中的来那度胺。