摘要
目的建立测定血液病患者鲁索替尼血药浓度的高效液相色谱-串联质谱法(HPLC-MS/MS),并用于血液病患者鲁索替尼的个体化给药。方法采用同位素内标法,通过含内标(鲁索替尼-d9)的甲醇沉淀蛋白,萃取鲁索替尼,用HPLC-MS/MS分离和测定鲁索替尼和鲁索替尼-d9。以鲁索替尼和鲁索替尼-d9峰面积比为定量依据,计算血浆鲁索替尼浓度,并考察其性能。结果鲁索替尼在2.5~250.0 ng/mL内线性关系良好,3个回归方程相关系数r均≥0.9950,携带污染率、重复性、实验室内精密度、回收率、基质效应和稳定性均符合性能验证要求。结论HPLC-MS/MS可快速、特异和准确地检测血液病患者血浆鲁索替尼浓度,能为临床合理使用鲁索替尼提供用药参考。
Objective To establish HPLC-MS/MS for determination of blood drug concentration of Ruxolitinib in patients with hematologic diseases and to be used for individualized administration of Ruxolitinib.Methods Using isotopic internal standard method,the Ruxolitinib-d9 and Ruxolitinib were released and extracted by protein precipitation method.Ruxolitinib and Ruxolitinib-d9 were separated and determined by HPLC-MS/MS.Ruxolitinib and Ruxolitinib-d9 peak area ratio were used to calculate the plasma Ruxolitinib concentration and the performance verification were also investigated.Results Ruxolitinib had good linearity in the range of 2.5-250.0 ng/mL,and the correlation coefficients of the three regression equations were all higher than 0.9950.Pollution,reproducibility,laboratory precision,recovery,matrix effect and stability all met the requirements of performance verification.Conclusion HPLC-MS/MS could quickly,specifically and accurately detect the concentration of Ruxolitinib,which could provide a reference for the rational use of Ruxolitinib in clinical practice.
作者
王磊
代玉超
王红春
刘红星
WANG Lei;DAI Yuchao;WANG Hongchun;LIU Hongxing(Department of Pathology&Laboratory Medicine,Hebei Yanda Lu Daopei Hospital,Langfang,Hebei 065201,China;Department of Anesthesiology,Women and Children′s Health Care Hospital of Donggang District,Rizhao,Shandong 276800,China;Department of Pathology&Laboratory Medicine,Beijing Lu Daopei Hospital,Beijing 100176,China;Beijing Lu Daopei Institute of Hematology,Beijing 100176,China)
出处
《检验医学与临床》
CAS
2021年第2期202-206,共5页
Laboratory Medicine and Clinic
