Ouyang Jin, Baeyens Willy R G, Duan Jingli, Delanghe Joris
Faculty of Pharmaceutical Sciences, Department of Pharmaceutical Analysis, Ghent University, Harelbekestraat 72, B-9000 Ghent, Belgium.
Biomed Chromatogr. 2003 Sep;17(6):404-10. doi: 10.1002/bmc.262.
A chromatographic method was developed for the determination of cyclosporin A in human whole blood using reversed-phase HPLC at room temperature. Most previous reports carried out this liquid chromatographic separation at temperatures above 70 degrees C. The present procedure greatly improves the detection limit by controlling peak broadening effects, as well as the lifetime of the column at room temperature. Under optimal conditions and using ketoconazole as an internal standard, the calibration graph was linear in the range of 16-1000 microg/L with a relative standard deviation of 3.72% at 150 microg/L and 2.45% at 300 microg/L (n = 11) of cyclosporin A. The detection limit was of 5.0 microg/L cyclosporin A. By this procedure, cyclosporin A pharmacokinetic parameters in healthy Chinese subjects were studied. The developed method could be applied to the quantification of cyclosporin A in human blood samples and allows the study of its pharmacokinetics in routine laboratories.
建立了一种在室温下使用反相高效液相色谱法测定人全血中环孢素A的色谱方法。以往大多数报告在70℃以上的温度下进行这种液相色谱分离。本方法通过控制峰展宽效应以及在室温下柱的使用寿命，大大提高了检测限。在最佳条件下，以酮康唑为内标，环孢素A的校准曲线在16 - 1000μg/L范围内呈线性，在150μg/L时相对标准偏差为3.72%，在300μg/L时相对标准偏差为2.45%（n = 11）。环孢素A的检测限为5.0μg/L。通过该方法，研究了健康中国受试者中环孢素A的药代动力学参数。所建立的方法可用于人血样品中环孢素A的定量分析，并允许在常规实验室中研究其药代动力学。
