Background: Cytotoxic drug residues in pharmacy intravenous admixture services (PIVAS) have always been a major problem for pharmaceutical workers and the PIVAS environment,which is not only pollutes the PIVAS environment, but also causes serious harm to the life and health of the staff. This study aimed to establish an ultra-high performance liquid chromatography quadrupole orbitrap high resolution mass spectrometry (UPLC-Q/Orbitrap-HRMS) method for the rapid detection and monitor of 15 cytotoxic drugs. Methods: UPLC-Q/Orbitrap-HRMS method was used to establish a rapid detection method for 15 cytotoxic drugs such as cytarabine, gemcitabine and so on. The daily precision and accuracy of this method were verified by injecting four concentrations of standard solution on the same day, and the same four concentrations of standard solution were injected within three days respectively to verify the daily precision of this method. The signal-to-noise ratio (SNR) of 10:1 was calculated as the limit of quantity. The mixed standard solution of 15 cytotoxic drugs with concentrations of 0.5, 1, 3, 10, 30, 100, 300, and 1,000 ng/mL was configured and detected by this method for linearity and range.The stability of this method was investigated using a mixture of 15 drugs (15MIX) standard solutions at high concentration (300 ng/mL) and low concentration (10 ng/mL) at room temperature for 12 and 24 hours, respectively. A standard solution of each drug, 15MIX and blank solution were taken to verify the exclusivity of the method. Results: The results showed that the method had good specificity, and the intraday precision of all drugs was less than 10% and the intraday precision was less than 15%. At the same time, the standard curve had good linearity, R-2 was greater than 0.99, and the limit of quantification of most drugs was about 1 ng/mL. Conclusions: In this study, an UPLC-Q/Orbitrap-HRMS method was established for the rapid detection of 15 cytotoxic drugs, providing technical support for the monitoring of cytotoxic drug residues in PIVAS, which is of great significance for environmental contamination mornitoring as well as occupational exposure alert.
基金：
Soochow Science and Technology Development Plan-Basic Research of Medical and Health Science and Technology Innovation Application [SKJYD2021164]; Livelihood Science and Technology-Key Technology Application Special Project of Suzhou Science and Technology Bureau [SS2019042]; Jiangsu Pharmaceutical Association [H202122]
第一作者机构：[1]Fudan Univ, Shanghai Canc Ctr, Dept Pharm, Shanghai, Peoples R China[2]Fudan Univ, Shanghai Med Coll, Dept Oncol, Shanghai, Peoples R China[3]Shanghai Jiao Tong Univ, Tongren Hosp, Dept Pharm, Sch Med, Shanghai, Peoples R China
共同第一作者：
通讯作者：
通讯机构：[1]Fudan Univ, Shanghai Canc Ctr, Dept Pharm, Shanghai, Peoples R China[2]Fudan Univ, Shanghai Med Coll, Dept Oncol, Shanghai, Peoples R China[4]Soochow Univ, Dept Pharm, Affiliated Hosp 2, Suzhou, Peoples R China[*1]Department of Pharmacy, The Second Affiliated Hospital of Soochow University, Suzhou, China.[*2]Department of Pharmacy, Shanghai Cancer Center, Fudan University, Shanghai, China Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China
推荐引用方式(GB/T 7714)：
Yu Bo,Wang Yang,Geng Zhou,et al.Establishment and validation of analytical methods for 15 hazardous drugs by UPLC-Q/Orbitrap-HRMS[J].ANNALS OF TRANSLATIONAL MEDICINE.2022,10(12):doi:10.21037/atm-22-2330.
APA：
Yu, Bo,Wang, Yang,Geng, Zhou,Qu, Yuchen,Pan, Jie&Zhai, Qing.(2022).Establishment and validation of analytical methods for 15 hazardous drugs by UPLC-Q/Orbitrap-HRMS.ANNALS OF TRANSLATIONAL MEDICINE,10,(12)
MLA：
Yu, Bo,et al."Establishment and validation of analytical methods for 15 hazardous drugs by UPLC-Q/Orbitrap-HRMS".ANNALS OF TRANSLATIONAL MEDICINE 10..12(2022)
