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| Determination of Bortezomib in rat plasma by UHPLC-MS/MS method |
| LIU Jin1 LIU Ke2 JIANG Wei3 HUANG Cuiyun3 DENG Yi3 SHU Chang3 ZHANG Feng3 |
1.Department of Hematology, Shanghai Changzheng Hospital, Shanghai 200003, China;
2.Department of Oncology, Shanghai Changzheng Hospital, Shanghai 200003, China;
3.Department of Pharmacy, Shanghai Changzheng Hospital, Shanghai 200003, China |
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Abstract Objective To establish an ultra high performance liquid chromatography-tandem mass spectrometry method for the determination of Bortezomib in rat plasma. Methods Plasma sample preparation was treated by protein precipitation. ColumWaters XBridge?誖 BEH C18 (2.5 μm, 50 mm × 2.1 mm) was used as the column. Acetonitrile and 10 mmol/L ammonium formate solution was used as the mobile phase, with gradient elute, the volume flow rate was 0.3 mL/min, the column temperature was maintained at at 35℃. Multi-reaction detection positive ion mode was used to analysis. Results The Bortezomib in the range of 0.5-100 ng/mL showed a good liner, the standard linear regression equation was Y = 14.41X-0.4490 (r = 0.9974). The lower limit of quantification was 0.5 ng/mL, and the results of in-day, day-time precision and accuracy, extraction recovery, matrix effect and stability of quality control samples with low, medium and high 3 mass concentrations were all good. Conclusion The method is accurate, sensitive and reproducible, and can be used in the pharmacokinetic study of Bortezomib in rats.
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[1] China Multiple Myeloma Working Group. Guidelines for the diagnosis and treatment of multiple myeloma in China [J]. Chin J Intern Med，2013，52（9）：791-795.
[2] Antonio P，Kenneth A. Multiple Myeloma [J]. N Engl J Med，2011，364（11）：1046-1060.
[3] Kumar SK，Callander NS，Alsina M，et al. NCCN Guidelines Insights：Multiple Myeloma，Version 3.2018 [J]. J Natl Compr Canc Netw，2018，16：11-20.
[4] Sun C，Li J，Chu Z，et al. Efficacy and safety of bortezomib maintenance in patients with newly diagnosed multiple myeloma：a meta-analysis [J]. Biosci Rep，2017，37（4）：BSR2 0170304.
[5] Einsele H，Engelhardt M，Tapprich C，et al. Phase Ⅱ study of bortezomib，cyclophosphamide and dexamethasone as induction therapy in multiple myeloma：DSMM Ⅺ trial [J]. Br J Haematol， 2017，179（4）：586-597.
[6] Richardson PG，Sonneveld P，Schuster MW，et al. Bortezomib or High-Dose Dexamethasone for Relapsed Multiple Myeloma [J]. N Engl J Med，2005，352（24）：2487-2498.
[7] Mai EK，Bertsch U，Durig J，et al. Phase Ⅲ trial of bortezomib，cyclophosphamide and dexamethasone （VCD） versus bortezomib，doxorubicin and dexamethasone （PAd） in newly diagnosed myeloma [J]. Leukemia，2015，29（8）：1721-1729.
[8] Moreau P，Hulin C，Macro M，et al. Bortezomib，Thalidomide and Dexamethasone （VTD） Is Superior to Bortezomib，Cyclophosphamide and Dexamethasone （VCD） Prior to Autologous Stem Cell Transplantation for Patients with De Novo Multiple Myeloma. Results of the Prospective IFM 2013-04 Trial [J]. Blood，2015，126（23）：393.
[9] Miguel JF，Schlag R，Khuageva NK，et al. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma [J]. N Engl J Med，2008，359（9）：906-917.
[10] Merz M，Salwender H，Haenel M，et al. Peripheral neuropathy associated with subcutaneous or intravenous bortezomib in patients with newly diagnosed myeloma treated within the GMMG MM5 phase Ⅲ trial [J]. Haematologica，2016，101（12）：e485-e487.
[11] Argyriou AA，Cavaletti G，Bruna J，et al. Bortezomib-induced peripheral neurotoxicity：an update [J]. Archives of Toxicology，2014，88（9）：1669-1679.
[12] Koh Y，Lee SY，Kim I，et al. Bortezomib-associated peripheral neuropathy requiring medical treatment is decreased by administering the medication by subcutaneous injection in Korean multiple myeloma patients [J]. Cancer Chemother Pharmacol， 2014， 74：653-657.
[13] Quinn DI，Nemunaitis J，Fuloria J，et al. Effect of the Cytochrome P450 2C19 Inhibitor Omeprazole on the Pharmacokinetics and Safety Profile of Bortezomib in Patients with Advanced Solid Tumours，Non-Hodgkin′s Lymphoma or Multiple Myeloma [J]. Clin Pharmacokinect，2009，48（3）：199-209.
[14] Iwamoto T，Ishibashi M，Fujieda A，et al. Drug Interaction Between Itraconazole and Bortezomib：Exacerbation of Peripheral Neuropathy and Thrombocytopenia Induced by Bortezomib [J]. Pharmacotherapy，2010，30（7）：661-665.
[15] Venkatakrishnan K，Rader M，Ramanathan RK，et al. Effect of the CYP3A inhibitor ketoconazole on the pharmacokinetics and pharmacodynamics of bortezomib in patients with advanced solid tumors：A prospective，multicenter，open-label，randomized，two-way crossover drug—drug interaction study [J]. Clin Ther，2009，31：2444-2458.
[16] Gosetti F，Mazzucco E，Gennaro MC，et al. Ultra high performance liquid chromatography tandem mass spectrometry determination and profiling of prohibited steroids in human biological matrices [J]. J Chromatogr B Analyt Technol Biomed Life Sci，2013，927：22-36.
[17] Adaway J，Keevil BG. Therapeutic drug monitoring and LC-MS/MS [J]. J Chromatogr B Analyt Technol Biomed Life Sci，2012，883-884：33-49.
[18] Pohanka A，Rosenborg S，Lindh JD，et al. Experiences from using LC-MS/MS for analysis of immunosuppressive drugs in a TDM service [J]. Clin Biochem，2016，49（49）：1024-1031.
[19] Rafael R，Laurence L，Marie A，et al. Liquid chromatography-tandem mass spectrometric assay for therapeutic drug monitoring of the EGFR inhibitors afatinib，erlotinib and osimertinib，the ALK inhibitor crizotinib and the VEGFR inhibitor nintedanib in human plasma from non-small cell lung cancer patients [J]. J Pharm Biomed Anal，2018，158：174-183.
[20] Shu C，Zeng T，Gao S，et al. LC-MS/MS method for simultaneous determination of thalidomide，lenalidomide，cyclophosphamide，bortezomib，dexamethasone and adriamycin in serum of multiple myeloma patients [J]. J Chromatogr B Analyt Technol Biomed Life Sci，2016， 1028：111-119. |
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