高效液相色谱法测定人血浆中齐拉西酮浓度  

Determination of Concentration of Ziprasidone in Human Plasma by HPLC with UV Detection

作　　者：谢宁 林志霞 杨红梅 梁小丽 肖春燕 XlE Ning LIN Zhi-xia YANG Hong-mei LIANG Xiao-li XIAO Chun-yan(Department of pharmacy Department of Neurology,Tianhe district hospital of maternal and child health in Guangzhou,Guangzhou 510620,China Department of pharmacy, Guangzhou women and children＇s medical center, Guangzhou 510120, China)

机构地区：[1]广州市天河区妇幼保健院药剂科,广州510620 [2]广州市天河区妇幼保健院神经内科,广州510620 [3]广州市妇女儿童医疗中心药学部,广州510120

出　　处：《海峡药学》2017年第10期33-36,共4页Strait Pharmaceutical Journal

摘　　要：目的建立测定人血浆中齐拉西酮浓度的高效液相色谱法。方法以Agilent C18反相柱(150mm×4.6mm,5μm)为色谱柱,流动相为50mmol·L-1醋酸铵(调p H 6.6)-乙腈-甲醇(20∶10∶70 V/V/V);流速:1.0m L·min-1;柱温:40℃;检测波长:258nm;灵敏度为0.01AUFS。以乙酸乙酯与二氯甲烷(80∶20 V/V)为提取剂。结果齐拉西酮的高、中、低(320.0,40.0,10.0ng·m L-1)3种浓度平均相对回收率分别为98.77%,97.89%,100.3%;提取回收率分别为77.65%,73.68%,71.12%。日内、日间差RSD均低于15%(n=5);分析方法的检测下限为3.0ng·m L-1;线性范围为5.0~480.0ng·m L-1,线性方程为:Y=7.29X-1.21,r=0.9989(n=7)。结论该方法灵敏、准确、简单、快速,可用于齐拉西酮临床血药浓度监测(TDM)和药动学研究。OBJECTIVE To establish a method for determining the concentration of ziprasidone in human plasma by HPLC. METHODS The drug from plasma was analyzed in a reverse phase HPLC system Agilent C18 column（ 150 mm × 4. 6 mm,5μm）; mobile phase consisted of 50 mmol·L-1 ammonioum-acetonitrile-methanol（ 20∶ 10∶ 70 V/V/V）; the flow rate was 1. 0 m L · min-1; the detection temperature was at 40℃,the detection wavelength was at258 nm. The sensitivity was 0. 01 AUFS. Ethyl acetate and dichloromethane was used as extracting solvent. RESULTS The average recoveries of ziprasidone in high,middle and low concentrations（ 320. 0,40. 0,10. 0 ng·m L-1） were98. 77%,97. 89% and 100. 3%,respectively. the extraction recovery were 77. 65%,73. 68% and 71. 12%,respectively. The intra-day and inter-day variation（ RSD） were less than 15%（ n = 5）. The calibration curve of carbamazepine showed good linearity,r = 0. 9989（ n = 7）,over the range of 5. 0 ~ 320. 0 ng·m L-1. The minimum detectable concentration of carbamazepine was 3. 0 ng·m L-1. The regression equation was Y = 7. 29 X ＋ 1. 21. CONCLUSION The method is sensitive,quick,simple and accurate,it can be used for clinical drug monitoring（ TDM） and pharmacokinetics studies of ziprasidone.

关 键 词：齐拉西酮 血药浓度 高效液相色谱法 药动学 

分 类 号：R969.1[医药卫生—药理学]