RP-HPLC法测定人血浆中齐拉西酮质量浓度

Determination of the concentration of ziprasidone in human plasma by using RP-HPLC

目的建立用反相高效液相色谱(RP-HPLC)法测定人血浆中齐拉西酮质量浓度的办法。方法以Acclaim^(TM)12 C_(18)反相柱(250mm×4.6mm,5μm)为色谱柱,流动相为0.2%三乙胺-甲醇(15∶85);流速:1.1mL/min;柱温:35℃;检测波长:230nm,以乙酸乙酯为萃取剂。结果齐拉西酮在8.0~300.0ng/mL质量浓度范围内,其质量浓度与峰面积呈良好线性关系;齐拉西酮低、中、高质量浓度(8.0、80.0、350.0ng/mL)相对回收率均大于95%;提取回收率均大于90%。日内、日间相对标准偏差均低于10%(n=5)。分析方法的检测限为5.0ng/mL;齐拉西酮的曲线方程:Y=1.193 X+0.013,r=0.999 7(n=7)。结论该法灵敏、简单、准确、快速,可用于临床齐拉西酮血药浓度的监测。

Objective To develop a method for determining the concentration of ziprasidone in human plasma by using HPLC.Methods The drug concentration of plasma was analyzed in a reverse phase HPLC system C18 column（250mm×4.6mm,5μm）;mobile phase consisted of 0.2%ammonium triethyamine-methanol（15∶85）;the flow rate was1.1mL/min;the column temperature was 35°C.The detection wavelength was at 230 nm.Ethyl acetate was used as extracting solvent.Results A good linearity range was 8.0-300.0ng/mL concentration of ziprasidone in plasma.The average recoveries of ziprasidone in low,middle and high concentrations（8.0,80.0,350.0ng/mL）over 95% respectively;the extraction recovery over 90%.The intra-day and inter-day variation（RSD）was less than10%（n=5）.The minimum detectable concentration of ziprasidone was 5ng/mL.The regression equation was Y=0.089 9 X+0.021 5.r=0.999 7（n=7）.Conclusion The method is fast,accurate,,sensitive and simple for clinical monitoring of ziprasidone in plasma.