【作者】 申屠建中； 周惠丽； 苏优；

【Author】 ZHOU Hui-li, SU You SHENTu Jian-zhong Lab of therapeutic drug monitoring, Clinical pharmaceutical centre, First affiliated hospital, College of medicine, Zhejiang University, Hangzhou, 310003, China;pharmacy department, College of medicine, Zhejiang University City college, Hangzhou, 310015, China)

【机构】 浙江大学医学院附属第一医院临床药学中心治疗药物监测研究室； 浙江大学城市学院医学院药学系；

【摘要】 目的建立测定人血浆中盐酸二甲双胍浓度的HPLC法。方法色谱柱为ZORBAX SB-Aq柱(4．6mm×250mm,5μm),流动相为水-乙睛(73:27)(内含10mmol磷酸二氢钠和5mmol 十二烷基磺酸钠),检测波长234nm,流速1．0mL·min-1。血浆样品用乙睛沉淀进行预处理。结果盐酸二甲双胍在11．6ng·mL-1-2320．0ng·mL-1浓度范围内线性良好(r=0．9999),方法的最低检测浓度为5ng·mL-1(S/N=3)。血浆中低、中、高3种浓度的方法回收率在1002．0％-103．68％,低、中、高3种浓度的日内、日间RSD(n=5)为1．22％-2.24％和2．15％-2．89％。结论此方法快速,准确,灵敏,适用于药代动力学研究和血药浓度监测更多还原

【Abstract】 Objective: To establish a HPLC method for the determination of metformin hydrochloride in human plasma. Method: metformin hydrochloride was analysed on ZORBAX SB-Aq colum(4.6mm×250mm, 5μm) at 25 ℃, mobile phase was acetonitrile-water (73:27)(consisted of 10mmol sodium dihydrogen phosphate and 5mmol SDS), the detection wavelength was 234nm, the flow rate was 1.0mL·min-1.The plasma samples were precipitated by acetonitrile. Results: The range of calibration curve was 11.6ng·mL-1-2320.0ng·mL-1 (r=0.9999).The lowest detectable concentration was 5ng·mL-1(S/N=3). The method recovery of low, medium and high concentration were within 100.20%-103.68%, and the RSD of intra-day and inter-day assay were within 1.22%-2.24% and 2.15%-2.89% respectively. Conclusion: The method is simple, sensitive, reproducible and suitable for the phamacokinetic study of metformin hydrochloride.更多还原