Establishment of Plasma Concentration Detection Method for 5-Fluorouracil and its Clinical Application
- VernacularTitle:氟尿嘧啶血药浓度检测方法的建立及其临床应用
- Author:
Guangzhao HE
;
Hongbo XUE
;
Quanliang YANG
;
Yanzhi BI
;
Kai LEI
;
Chengliang ZHANG
- Keywords:
5-Fluorouracil;
Liquid chromatography tandem mass spectrometry;
Plasma drug concentration;
Clinical application
- From:
China Pharmacist
2017;20(1):49-52
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish a liquid chromatography tandem mass spectrometry ( LC-MS/MS) method for the determination of 5-fluorouracil (5-Fu) in patient’s plasma and apply it in clinics patients validation. Methods:5-Fu was analyzed on an Agela Inno-val NH2 (2. 1 mm × 50 mm, 5 μm) column. Methanol:ultra pure water (2 ∶98) was used as the mobile phase with isocratic elution. The flow rate was 0. 3 ml ·min-1 and the column temperature was set at 40℃. The ion transitions with electrospray ionization negative model were m/z 128. 8→42. 1 and m/z 188. 6→42. 1 for 5-Fu and 5-bromouracil (the internal standard), respectively. The LC-MS/MS method was verified according to the guideline of quantitative analysis validation of biological samples ( Chinese Pharmacopoeia, 2015 edition, the fourth part) . Results:The calibration curve of 5-Fu was linear within the range of 10-1 000 ng · ml-1 . The lower limit of quantification was 10 ng · ml-1 . The precision, accuracy, matrix effect and stability within the linear range were all in line with the requirements of method validation. Conclusion:The LC-MS/MS method developed in the study for the determination of 5-Fu is simple, rapid, accurate and reproducible, which can be used for the plasma concentration detection of 5-Fu in patients.
