高效液相色谱法测定人血浆盐酸特比萘芬浓度

Determination of Terbinafine Hydrochloride in Human Plasma by HPLC

目的建立测定人血浆盐酸特比萘芬浓度的高效液相色谱法。方法以利洛司酮作内标,三氯甲烷为提取溶剂,色谱柱Acclaim C18柱(250 mm×4.6 mm,5μm),流动相为甲醇-乙腈-0.01 mol.L-1磷酸二氢钾缓冲液(pH值3.9)(5:45:50),流速1.0 mL.min-1。检测波长224 nm。结果血浆盐酸特比萘芬浓度在0.04～2.40 mg.L-1范围内线性关系良好,加权最小二乘法进行回归运算得回归方程为C=0.003 2Y+0.051 3,相关系数r=0.998 6(n=7),最低检测浓度为0.04 mg.L-1。方法回收率为99.2%～102.5%,日内RSD<12%,日间RSD<8%。结论该方法操作简便,灵敏度高,重复性好,能快速准确测定人血浆盐酸特比萘芬浓度。

Objective To establish a method for determining concentration of terbinafine hydrochloride in human plasma by HPLC. Methods Lilopristone was chosen as the internal standard. Chloroform was used for extraction. Acclaim C18 column （250 mm × 4.6 mm,5 μm）was used and the mobile phase was composed of methanol -acetonitrile-0.01 mol ·L^-1 potassium dihydrogen phosphate buffer （pH 3.9） （5 ： 45 ： 50） ,eluted at a flow rate of 1.0 mL ·min^-1. UV detection wavelength was set at 224 nm Results A good linear calibration curves was obtained at the range of 0.04 - 2.40 mg ·L^-1. The regression equation was C = 0.003 2 Y ＋ 0. 051 3 ,r = 0.998 6 （n = 7 ） calculated by least square method. The detection limit was 0.04 mg ·L^-1 and the recovery was 99.2% - 102.5% with intra-day RSD less than 12% and inter-day RSD less than 8%. Conclusion This method is simple, sensitive, accurate and reproducible for concentration determination of terbinafine hydrochloride in plasma.