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人血浆中安罗替尼质量浓度测定方法的建立及其应用
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| 篇名： | 人血浆中安罗替尼质量浓度测定方法的建立及其应用 |
| TITLE： | Establishment and Application of Method for Concentration Determination of Anlotinib in Human Plasma |
| 摘要： | 目的：建立测定人血浆中安罗替尼质量浓度的方法并应用于临床。方法：以醋酸铵为盐析助剂，以乙腈为溶剂，采用盐析辅助液液萃取对血浆样品进行前处理；以伏立康唑为内标，采用液相色谱-串联质谱法（LC-MS/MS）测定。色谱柱为WatersXBridgeC18，流动相为0.2％甲酸水溶液-乙腈（梯度洗脱），流速为1mL/min，柱温为40℃，进样量为10μL，分流比为3∶7；离子源为电喷雾离子源，以多反应监测模式进行正离子扫描，用于定量分析的离子对分别为m/z408.3→339.3（安罗替尼）、m/z350.2→281.3（内标）。结果：安罗替尼检测质量浓度的线性范围为0.2～200ng/mL（R2＝0.9967）；定量下限为0.2ng/mL；日内、日间精密度试验的RSD均小于12％（n＝6或n＝3）；准确度为90.92％～108.00％（n＝6或n＝3）；平均提取回收率为87.51％～100.00％（RSD＜8％，n＝6）；平均基质效应为96.66％～99.93％（RSD＜5％，n＝6）。3例使用安罗替尼治疗的非小细胞肺癌患者体内的血药浓度为8.74～65.60ng/mL。结论：该方法操作简单、准确度高、专属性强，可用于非小细胞癌患者体内安罗替尼的血药浓度监测。 |
| ABSTRACT： | OBJECTIVE：To establish a method for concentration determination of anlotinib in human plasma and apply it in the clinic. METHODS ：The plasma samples were pretreated by salting-out assisted with liquid-liquid extraction with ammonium acetate as salting out assistant and acetonitrile as solvent. Using voriconazole as internal standard ，LC-MS/MS method was adopted. The separation was performed on Waters X Bridge C 18 column with mobile phase consisting of 0.2％ formic acid solution- acetonitrile（gradient elution ）at the flow rate of 1 mL/min. The column temperature was set at 40 ℃，and sample size was 10 μL. The split ratio was 3∶7. The electrospray ion source and multiple reaction monitoring mode were used for the analysis. The ion pair of anlotinib and internal standard under positive ion mode were m/z 408.3→339.3 and m/z 350.2→281.3，respectively. RESULTS ： Anlotinib showed a good linear relationship in the concentration range of 0.2-200 ng/mL（R2＞0.996 7）. The lowest limit of quantitation was 0.2 ng/mL. Intra-day and inter-day RSDs were no more than 12％ （n＝6 or n＝3）. Accuracies were 90.92％-108.00％（n＝6 or n＝3）. The average extraction recoveries were 87.51％-100.00％（RSD＜8％，n＝6）. The average matrix effects were 96.66％-99.93％（RSD＜5％，n＝6）. The plasma concentration of 3 patients with NSCLC treated with anlotinib was 8.74-65.60 ng/mL. CONCLUSIONS ：The method is simple ，accurate and specific ，and is suitable for the plasma concentration monitoring of anlotinib in NSCLC patients. |
| 期刊： | 2021年第32卷第11期 |
| 作者： | 周利娟，武正华，汪硕闻，缪文清，包婺平，包爱华，范国荣 |
| AUTHORS： | ZHOU Lijuan ，WU Zhenghua ，WANG Shuowen ，MIAO Wenqing ，BAO Wuping ，BAO Aihua，FAN Guorong |
| 关键字： | 安罗替尼；液相色谱-串联质谱技术；盐析辅助液液萃取；治疗药物监测 |
| KEYWORDS： | Anlotinib；LC-MS/MS；Salting-out assisted liquid-liquid extraction ；Therapeutic drug monitoring |
| 阅读数： | 465 次 |
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