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LC-MS/MS法测定人血浆中吡咯替尼的浓度及其临床应用
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| 篇名： | LC-MS/MS法测定人血浆中吡咯替尼的浓度及其临床应用 |
| TITLE： | Determination of Pyrrotinib Concentration in Human Plasma by LC-MS/MS and Its Clinical Application |
| 摘要： | 目的：建立测定吡咯替尼血药浓度的方法，并应用于临床。方法：血浆样本经甲醇沉淀蛋白后，以伊马替尼为内标，采用液相色谱-串联质谱（LC-MS/MS）法测定。以UltimateAQ-C18为色谱柱，以甲醇（含0.1％甲酸）-水（0.1％甲酸）为流动相进行梯度洗脱，流速为0.4mL/min，柱温为40℃，进样量为5µL。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/z583.4→138.3（吡咯替尼）、494.5→393.4（内标）。选择2020年6－11月于青岛大学附属医院接受吡咯替尼治疗的乳腺癌患者30例，测定其用药1周后的吡咯替尼稳态谷浓度。结果：吡咯替尼检测质量浓度的线性范围为5～300ng/mL（r＝0.9993），定量下限为5ng/mL；日内、日间RSD均不高于9.30％，相对误差为－6.70％～5.04％；稳定性试验的相对误差为－1.92％～5.42％；提取方法、基质效应、残留效应均不影响待测物的定量分析。30例乳腺癌患者体内吡咯替尼的稳态谷浓度为32.6～82.8ng/mL，平均血药浓度为53.8ng/mL，存在2.54倍的个体差异。结论：所建LC-MS/MS法操作简便、灵敏度和准确度较高，可用于乳腺癌患者体内吡咯替尼的血药浓度监测。 |
| ABSTRACT： | OBJECTIVE：To establish a method for the determination of pyrrotinib concentration in plasma ，and apply it in clinic. METHODS ：After precipitated with methanol ，the plasma sample was determined by LC-MS/MS using imatinib as internal standard. The determination was performed on Ultimate AQ-C 18 column with mobile phase consisted of methanol （containing 0.1％ formic acid ）and water （containing 0.1％ formic acid ）（gradient elution ）at the flow rate of 0.4 mL/min. The column temperature was 40 ℃，and the sample size was 5 µL. The ion source was electrospray ionization source ，and the positive ion scanning was carried out in multiple reaction mode. The ion pairs for quantitative analysis were m/z 583.4→138.3（pyrrotinib）and m/z 494.5→ 393.4（internal standard ），respectively. Thirty breast cancer patients taking pyrrotinib were collected from the Affiliated Hospital of Qingdao University during Jun.-Nov. 2020 to determine their steady-state trough concentrations of pyrrotinib after a week of treatment. RESULTS ：The linear range of pyrrotinib were 5-300 ng/mL（r＝0.999 3）. The lower limit of quantification was 5 ng/mL. RSDs of intra-day and inter-day were not higher than 9.30％，and relative errors （REs）ranged －6.70％-5.04％. REs of stability tests were in the range of －1.92％-5.42％. The extraction method ，matrix effect and residual effect did not affect the quantitative analysis of the substance to be tested. The steady-state trough concentrations of pyrrotinib were 32.6-82.8 ng/mL，with an average plasma concentration of 53.8 ng/mL；there was about 2.54 fold individual difference. CONCLUSIONS ：Established LC-MS/MS method is simple ，sensitive and accurate ，and can be used for the plasma concentration monitoring of pyrrotinib in breast cancer patient. |
| 期刊： | 2021年第32卷第22期 |
| 作者： | 赵振寰，荆伟丽，刘涛，吕志强，曹志红，徐文 |
| AUTHORS： | ZHAO Zhenhuan ，JING Weili，LIU Tao，LYU Zhiqiang ，CAO Zhihong ，XU Wen |
| 关键字： | 吡咯替尼；液相色谱-串联质谱法；伊马替尼；乳腺癌；血药浓度监测 |
| KEYWORDS： | Pyrrotinib；LC-MS/MS；Imatinib；Breast cancer ；Plasma concentration monitoring |
| 阅读数： | 284 次 |
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