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目的 :建立用气 -质联用仪测定抗焦虑新药 (AF - 5 )的血药浓度的分离分析方法 ,并对AF - 5不同剂型的血药浓度进行测定。方法 :血浆样品经正己烷一石油醚 (9∶1)提取 ,以高纯氦为载气 ,DB - 5MS毛细管柱 ,正二十一烷为内标进行定性定量分析。结果 :检测限为 0 0 5 6ng (S N =6 ) ,最低检测浓度为 8 5ng·mL- 1 血浆。AF - 5的血药浓度在 8 5～ 110 0ng·mL- 1 范围内线性关系良好。回收率为 81 6 %。结论 :该方法操作简便 ,特异性强 ,重现性好 ,适用于药代动力学研究和血药浓度监测。
OBJECTIVE: To establish a method for the separation and analysis of plasma concentration of anti - anxiety drug (AF - 5) by gas chromatography - mass spectrometry, and to determine the plasma concentration of different AF - 5 dosage forms. Methods: The plasma samples were extracted with n - hexane petroleum ether (9: 1). Qualitative and quantitative analysis was performed with high purity helium as carrier gas, DB - 5MS capillary column and n - Results: The detection limit was 0 0 5 6 ng (S N = 6) and the lowest detection concentration was 85 ng · mL -1 plasma. The plasma concentration of AF - 5 in the range of 8 5 ~ 110 0ng · mL-1 has a good linear relationship. The recovery rate was 81 6%. Conclusion: The method is simple, specific, reproducible and suitable for pharmacokinetic studies and plasma concentration monitoring.