| 摘要: |
| 目的：建立测定人全血中西罗莫司浓度的超高压液相色谱-串联质谱（UPLC-MS/MS）方法。方法：色谱柱为Agilent SB-C18（2.1 mm×50 mm，1.8 μm），流动相为水（A）-乙腈（0.1%甲酸，B），流速0.3 mL/min，梯度洗脱。依维莫司为内标，电喷雾离子源，多反应离子监测模式，正离子模式检测。西罗莫司和依维莫司离子对分别为m/z 936.5/409.5、980.6/389.3。同时采用该方法对我院血管瘤患儿西罗莫司血药浓度进行监测。结果：西罗莫司在0.625~40.000 ng/mL浓度范围内相对峰面积线性关系良好（R2=0.999 5），日内、日间RSD均小于10%，提取回收率91.95%~118.50%，基质效应81.67%~107.84%。结论：本方法灵敏、准确、快速，能满足临床常规监测西罗莫司血药浓度的需求 |
| 关键词: 西罗莫司 超高压液相色谱-串联质谱 血管瘤 儿童 治疗药物浓度监测 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2022.11.004 |
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| 基金项目: |
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| Establishment of Sirolimus Blood Concentration Monitoring Method and Its Application in Children with Hemangioma |
| Lin Zhiyan, Huang Xiaohui, Yang Ping |
| (Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 200092, China) |
| Abstract: |
| Objective: To establish the ultra high pressure liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method for determination of sirolimus in human whole blood. Methods: The analysis was carried out on the Agilent SB-C18 (2.1 mm×50 mm, 1.8 μm) column with gradient elution. The mobile phase was water (A)-acetonitrile (0.1% formic acid, B) at a flow rate of 0.3 mL/min. Everolimus was used as internal standard. The determination was performed on a triple quadrupole tandem mass spectrometer by multiple reactions monitoring mode via electrospray ionization source. The quantitative ion transition m/z of sirolimus and everolimus were 936.5/409.5 and 980.6/389.3. Meanwhile, the blood concentration of sirolimus in children with hemangioma was monitored by this method. Results: Sirolimus showed good linearity (r=0.999,7) in relative peak area over the concentration range of 0.625 to 40.000 ng/mL with intra-day and inter-day RSD less than 10%, extraction recoveries from 91.95% to 118.50% and matrix effects from 81.67% to 107.84%. Conclusion: The method is sensitive, accurate and rapid for monitoring of whole blood concentration of sirolimus, which can meet the needs of routine clinical monitoring of sirolimus blood concentration |
| Key words: sirolimus ultra high pressure liquid chromatography-tandem mass spectrometry hemangioma children therapeutic drug monitoring |
