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AcclaimTM 120 C18反相柱（250 mm ×4．6 mm ，5μm）为色谱柱，流动相为0．2％三乙胺‐甲醇（15∶85）；流速：1．1 mL／min；柱温：35℃；检测波长：230 nm ，以乙酸乙酯为萃取剂。结果齐拉西酮在8．0～300．0 ng／m L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、350．0 ng／m L ）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5．0 ng／mL ；齐拉西酮的曲线方程：Y＝1．193X＋0．013，r＝0．9997（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(250 mm × 4 .6 mm ,5 μm);mobile phase consisted of 0 .2% ammonium triethyamine‐methanol(15∶85);the flow rate was1 .1 mL/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 .0 ng/mL concentration of ziprasidone in plasma .The average recoveries of ziprasidone in low ,middle and high con‐centrations(8 .0 ,80 .0 ,350 .0 ng/mL) over 95% respectively ;the extraction recovery over 90% .The intra‐day and inter‐day varia‐tion(RSD)was less than10% (n=5) .The minimum detectable concentration of ziprasidone was 5 ng/mL .The regression equation was Y=0 .089 9X+0 .021 5 .r=0 .999 7(n=7) .Conclusion The method is fast ,accurate ,,sensitive and simple for clinical monito‐ring of ziprasidone in plasma .
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