HPLC法测定人血清中甲磺酸齐拉西酮浓度  

Determination of concentration of ziprasidone mesilate in human serum by HPLC

作　　者：李琰 瞿发林[1] 陈颖[1] 陈方斌[1] 林芝 钱霖 LI Yan;QU Falin;CHEN Ying;CHEN Fangbin;LIN Zhi;QIAN Lin(Department of Clinical Pharmacy,The 102nd Hospital of PLA,Changzhou 213003,China)

机构地区：[1]中国人民解放军第102医院临床药学科,常州213003

出　　处：《中国临床药学杂志》2019年第1期44-46,共3页Chinese Journal of Clinical Pharmacy

基　　金：南京军区医学创新课题基金资助(编号14ZX04)

摘　　要：目的建立HPLC法用于检测人血清中甲磺酸齐拉西酮浓度。方法采用ZE Month Crest ODS-L(250 mm×4.6 mm,5μm)色谱柱;流动相0.03 mol·L^(-1)磷酸二氢钾溶液(调pH 4.5)-甲醇(30∶70);流速1.0 mL·min^(-1);柱温35℃;检测波长210 nm。以乙酸乙酯-二氯甲烷(80∶20)为提取剂。考察该方法的专属性、标准曲线与定量下限、精密度与回收率及稳定性。结果甲磺酸齐拉西酮血药浓度在10.0～1 000μg·L^(-1)时线性关系良好,线性方程为y=1 041.9x-3.91(r=0.999 5),方法回收率为99.05%～101.82%,提取回收率为98.12%～110.59%。日内、日间精密度均<15%。结论该方法灵敏、简单、快速和准确,可用于临床甲磺酸齐拉西酮血药浓度监测和药动学研究。AIM To establish a method for determining the concentration of ziprasidone mesilate in human serum by HPLC.METHODS The drugs from serum was analyzed by a reverse phase HPLC system ZE Month Crest ODS-L chromatographic column(250 mm ×4.6 mm,5 μm);mobile phase consisted of 0.03 mol·L^-1 postassium dihydeogen phosphate(pH 4.5)-methanol (30:70);the flow rate was 1.0 mL·min^-1 and the column temperature was 35℃;the detection wavelength was at 210 nm.Ethyl acetate and dichloromethane (80:20)was used as extracting solvent.And then the specificity,lower limit of quantitation an standard curve,precision and recovery rate and stability of the method were investigated.RESULTS The calibration curves were linear in the range of 10.0 -1 000.0 μg ·L^-1 for ziprasidone mesilate,and the regression equation of ziprasidone mesilate was y =1 041.94 -3.91 (r =0.999 5).The relative recovery rate ranged from 99.05%to 101.82%and the absolute recovery rate ranged from 98.12%to 110.59%.The intra-day and inter-day variation(RSD)was less than 15%.CONCLUSION The method is sensitive,accurate,simple and quick,and it can be used for clinical drug monitoring and pharmacokinetic studies of ziprasidone mesilate.

关 键 词：甲磺酸齐拉西酮 血药浓度 高效液相色谱法 

分 类 号：R969[医药卫生—药理学]