高效液相色谱法测定人血浆中氯氮平和氨磺必利浓度研究  

Determination of clozapine and amisulpride in human plasma by high performance liquid chromatography

作　　者：陈颖[1] 瞿发林[1] 李琰[2] 林芝[1] 陈方斌[1] 李宁[1] 

机构地区：[1]解放军第102医院,江苏常州213003 [2]南京中医药大学翰林学院,江苏泰州225300

出　　处：《中国临床药理学杂志》2015年第21期2140-2142,共3页The Chinese Journal of Clinical Pharmacology

基　　金：南京军区医学创新课题基金资助项目(14ZX04)

摘　　要：目的：建立HPLC法同时检测人血浆中氯氮平和氨磺必利浓度的方法。方法用ZE Month Crest ODS－L色谱柱（4．6 mm ×250 mm，5μm）；流动相为30 mmol· L－1磷酸二氢钾（调pH 7．5）－甲醇（35∶65）；流速为1．0 mL· min－1；柱温为35℃；检测波长为270 nm。以乙醚为提取剂。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。结果氯氮平血药浓度在10～1000 ng· mL－1线性关系良好，线性方程为Y＝4．20×10－3 C－3．13×10－2（ r＝0．9994），方法回收率为91．89％～95．18％，提取回收率为93．78％～107．70％。氨磺必利血药浓度在10～1000 ng· mL－1线性关系良好，线性方程为Y＝3．60×10－3C－3．12×10－2（r＝0．9992），方法回收率为92．98％～95．51％，提取回收率为91．50％～96．54％。日内、日间精密度均小于15％。结论该方法灵敏，简单，快速，准确，可用于临床氯氮平和氨磺必利血药浓度监测和药代动力学研究。Objective To establish a method for simultaneously determining the concentration of clozapine and amisulpride in human plasma by HPLC.Methods The drugs from plasma was analyzed in a reverse phase HPLC system ZE Month Crest DDS-L column （4.6 mm × 250 mm,5 μm）; mobile phase consisted of 30 mmol· L-1 postassium dihydeogen phosphate （ pH 7.5） -methanol （35∶65）;the flow rate was 1.0 mL· min-1 and the column temperature was 35 ℃; the detection wavelength was at 270 nm.Ether was used as extracting solvent.And then the specificity, lower limit of quantitation and standard curve, precision and recovery rate and stability of the method were investigated. Results The calibration curves were linear in the range of 10 -1000 ng· mL-1 for clozapine, the regression equation of clozapine was Y=4.20 ×10 -3 C -3.13 ×10 -2 （r=0.999 4）.The relative recovery rate ranged from 91.89% to 95.18% and the absolute recovery rate ranged from 93.78%to 107.70%.The calibration curves were linear in the range of 10-1000 ng· mL-1 for amisulpride, the regression equa-tion of amisulpride was Y=3.60 ×10 -3 C-3.12 ×10 -2 （ r=0.999 2 ） . The relative recovery rate ranged from 92.98%to 95.51%and the abso-lute recovery rate ranged from 91.50%to 96.54%.The intra-day and inter-day variation （ RSD） were both lower than 15%.Conclusion The method is sensitive, accurate, simple and quick, it can be used for clinical drug monitoring and pharmacokinetics studies of clozapine and amisulpride.

关 键 词：氯氮平 氨磺必利 血药浓度 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学] R971.4[医药卫生—药学]