LC-MS/MS method for simultaneous determination of thalidomide, lenalidomide, cyclophosphamide, bortezomib, dexamethasone and adriamycin in serum of multiple myeloma patients
LC-MS/MS method for simultaneous determination of thalidomide, lenalidomide, cyclophosphamide, bortezomib, dexamethasone and adriamycin in serum of multiple myeloma patients
复制标题
LC-MS/MS法同时测定多发性骨髓瘤患者血清中沙利度胺、来那度胺、环磷酰胺、硼替佐米、地塞米松和阿霉素
DOI：
10.1016/j.jchromb.2016.06.009
复制
发表时间：
2016-08-15
影响因子：
3
通讯作者：
Chen, Wansheng
中科院分区：
文献类型：
--
作者：
Shu, Chang;Zeng, Tianmei;Chen, Wansheng
多发性骨髓瘤（MM）是一种严重威胁人类健康的恶性肿瘤性血清细胞疾病。沙利度胺、来那度胺、环磷酰胺、硼替佐米、地塞米松和阿霉素等6种常用药物浓度的测定具有重要的临床意义。在此，我们报告了一种快速和同时测量上述治疗药物的液相色谱-串联质谱（LC-MS/MS）方法与固相萃取。在沃茨XBridge（R）BEH C18柱上进行分析（2.5 μ m，2.1 mm x 50 mm），以甲酸水溶液和乙腈为移动的相，流速为0.3 mL/min。所有分析物均表现出良好的相关系数沙利度胺、来那度胺、环磷酰胺、硼替佐米、地塞米松和阿霉素的定量下限分别为4、2、2、2、2和2 ng/mL。日间、日内精密度和稳定性以变异系数在15%以内、相对误差小于15%表示。按照美国FDA（2013年，修订版1）的要求，根据2015年版中国药典指导原则，对稀释效应、残留和真实样品再分析进行了研究。本文中描述的基于LC-MS/MS的分析可能会改善未来评估MM治疗常用疗法的临床研究。(C)2016爱思唯尔B. V.保留所有权利。
Multiple myeloma (MM), a malignant neoplastic serum-cell disorder, has been a serious threat to human health. The determination of 6 commonly used drug concentrations, including thalidomide, lenalidomide, cyclophosphamide, bortezomib, dexamethasone and adriamycin, in MM patients was of great clinical interest. Herein, we reported a method for the rapid and simultaneous measurement of the above therapeutics by liquid chromatography-tandem mass spectroscopy (LC-MS/MS) method with solid phase extraction. Analysis was performed on a Waters XBridge (R) BEH C18 column (2.5 mu m, 2.1 mm x 50 mm), with formic acid aqueous solution and acetonitrile as the mobile phase at flow rate 0.3 mL/min. All analytes showed good correlation coefficients (r > 0.996), and LLOQ of thalidomide, lenalidomide, cyclophosphamide, bortezomib, dexamethasone and adriamycin were 4, 2, 2, 2, 2 and 2 ng/mL, respectively. The inter- and intra-day precisions and stability were expressed as variation coefficients within 15% and relative error less than 15%. Dilution effect, carryover and incurred sample reanalysis were investigated according to the 2015 edition Chinese Pharmacopoeia guidelines, as US FDA (2013, revision 1) required. The LC-MS/MS based assay described in this article may improve future clinical studies evaluating common therapeutics for MM treatment. (C) 2016 Elsevier B.V. All rights reserved.