摘要
目的建立同时测定人血浆中齐拉西酮与阿立哌唑浓度的反相高效液相色谱法。方法以DiamonsilTM C18反相柱(150 mm×4.6 mm,5μm)为色谱柱,流动相为0.03 mol.L-1醋酸铵-甲醇(14∶86);流速:0.8 mL.min-1;柱温:40℃;检测波长:254 nm。以乙酸乙酯与二氯甲烷(80∶20)为提取剂。结果齐拉西酮在20.0～640.0 ng.mL-1、阿立哌唑在25.0～1 000.0 ng.mL-1浓度范围内,峰面积与其浓度呈良好线性关系;齐拉西酮、阿立哌唑的高、中、低浓度相对平均回收率分别为96.95%,97.71%,100.21%和97.87%,98.36%,101.82%,提取回收率分别为71.42%,74.33%,78.26%和72.67%,76.51%,79.32%;日内、日间RSD均<9%(n=5)。分析方法的检测限10.0 ng.mL-1;齐拉西酮曲线方程:Y=61.717X+2.16r,=0.998 9(n=7);阿立哌唑曲线方程:Y=87.946X+1.37r,=0.999 1(n=7)。结论该方法灵敏、准确、简单、快速,可用于临床齐拉西酮与阿立哌唑的血浆浓度监测和药动学研究。
Objective To establish a method for de.terrnining the concentration of ziprasidone and aripiprazole in human plasma by RP-HPLC. Methods The plasma level of drugs were analyzed by a reverse phase HPLC system with a C18 column （150 mm×4.6 mm, 5μm）, 0.03 mol·L^-1 ammonioum-methanol（ 14 ： 86 ） as mobile phase, flowing at 0.8 mL · min^-1, and the detection wavelength at 254 nm. Ethyl acetate and dichloromethane （80 ： 20） were used as extracting solvent. Results The relation of peak area and concentration showed linear in the range of 20. 0 - 640. 0 ng · mL^-1 for ziprasidone, 25. 0 - 1 000.0 ng· mL^-1 for aripiprazole, respectively. The average recoveries of ziprasidone and aripiprazole at high, middle and low concentrations were 96.95% ,97.71% , 100.21% and 97.87% , 98.36% , 101.82% , respectively; the extraction recovery was 71.42% , 74.33% , 78.26% and 72.67% , 76.51%, 79.32% , respectively. The intra-day and inter-day variations （RSD） were less than 9% （ n = 5 ）. The minimum detectable concentration was 10.0 ng· mL^-1. The regression equation of ziprasidone was Y= 61. 717X＋2.16, r = 0. 998 9 （ n = 7） and aripiprazole was Y= 87. 946X＋ 1.37, r = 0. 999 1 （ n = 7 ）, respectively. Conclusion The method is sensitive, accurate, simple and quick, which can be used for clinical drug monitoring and pharmacokinetic studies of ziprasidonc and aripiprazole.
出处
《医药导报》
CAS
2011年第8期1000-1003,共4页
Herald of Medicine
基金
广东省自然科学基金资助项目(基金编号:8151037001000001)
