摘要
目的建立高效液相色谱法测定西罗莫司血药浓度,测定该药在肝移植患者中的药代动力学参数。方法以沉淀-萃取法处理全血样品,采用Hypersil ODS C18(250 mm×4.6 mm,5μm)柱,柱温为50℃,乙腈-甲醇-水(7.5:62.5:30)为流动相,流速1.2 mL/min,以32-去甲基雷帕霉素为内标,在276 nm波长处,检测西罗莫司血药浓度,并应用此方法测定5例肝移植患者的西罗莫司血药浓度。结果全血中西罗莫司浓度在2.0～50.0ng/mL范围内线性良好(r=0.999 7),平均相对回收率为99.1%(n=5)。5例肝移植患者的Cmax为(12.66±4.1)ng/mL,t1/2为(19.2±11.2)h,tmax为(1.8±0.3)h。结论本方法快速、简便、准确,灵敏度高,重现性好,可用于肝移植患者的西罗莫司临床药物监测。
Objective To establish an HPLC method to determine the concentration of sirolimus in whole blood. Methods The whole-blood samples were pretreated by precipitation-extraction method,and sirolimus was determined by HPLC-UV.Hypersil ODS C18 analysis column（250 mm×4.6 mm,5 μm）was used,and the temperature was set at 50 ℃.The mobile phase was a mixture of acetonitrile-methanol-water（7.5：62.5：30）with a flow rate of 1.2 mL/min.The detection wavelength was set at 276 nm. Results The calibration curve was linear within the range 2.0～50 ng/mL（r=0.999 7）.The mean relative recovery was 99.1%,and the mean absolute recovery was 82.2%（n=5）.The intra-day and the inter-day relative standard deviation did not exceed 3.3% and 6.3% respectively.In the five transplantation receptors,Cmax was（12.66±4.1）ng/mL,t1/2 was（19.2±11.2）h,tmax was（1.8±0.3）h. Conclusion This method is simple,rapid,sensitive and suitable for therapeutic drug monitoring of sirolimus.
出处
《实用药物与临床》
CAS
2011年第1期28-30,共3页
Practical Pharmacy and Clinical Remedies
