RP-HPLC法测定人血浆中盐酸依托必利的浓度  

Determination of Itopride Hydrochloride in Human Plasma by RP-HPLC

作　　者：汪新亮[1] 吴基良[2] 

机构地区：[1]咸宁学院中心实验室,湖北咸宁437100 [2]咸宁学院药学院

出　　处：《咸宁学院学报（医学版）》2007年第1期23-26,共4页Journal of Xianning Univarsity(medical Sciences)

摘　　要：目的建立血浆中盐酸依托必利浓度的反相高效液相色谱（RP-HPLC）测定法,用于血药浓度监测以及生物利用度和药物动力学研究。方法含盐酸依托必利的血浆样品经液-液萃取后,通过C18（150.0mm×4.0mm,5μm）色谱柱,柱温25℃,流动相为甲醇∶0.1mol/L醋酸铵（80∶20,v/v）,冰醋酸调pH值3.8,流速：1ml/m in,荧光检测器,检测波长：激发波长（λEx）=304nm,发射波长（λEm）=344nm进行分离。结果血浆中杂质不干扰样品测定,在15.00~1000.00ng/m l范围线性良好（n=8）,最低可定量浓度为15.00ng/m l（信噪比〉3）,回收率大于90.00%,日内和日间精密度RSD均小于2.00%（n=5）,在室温流动相稳定性RSD小于3.00%（n=5）,反复冻融稳定性RSD小于8.00%（n=5）。结论该法快速、灵敏、准确,适合盐酸依托必利的血药浓度监测,并且对色谱柱的损害较小。Objective To develop a convenient method for the determination of itopride concentration in human plasma for pharmacokinetic and bioavailability study. Methods After abstracted from human plasma, itopride was analyzed by HPLC. In HPLC system,we used Cls （ 150.0mm ×4.0mm,5μm） as the analytical colurnn, ammonium acetate water solution ： methanol （ 80： 20, v/v, pH = 3.8 ） as the analytical mobile phase, and fluorescent spectrophotometer as the detector with λEx = 304nm, λEm = 344nm. Results The method had good linear relationship from 15.00 - 1000.00ng/ml（ n = 8 ） ,The detection limit was 15.00ng/ml. The recovery rate was more than 90.00%. The relative standard deviation （ RSD ） of inter-day and intra-day accuracy tests were both less than 2.00% （n = 5）. The RSD of stability test in mobile phase was less than 3.00% （n = 5）. Conclu- sion The method is simple, precise and sensitive. It can be used for determination of itopride in human plasma. The harm done to analyical column is little.

关 键 词：盐酸依托必利 血浆药物浓度 反相高效液相色谱-荧光法 

分 类 号：R927.11[医药卫生—药学]