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目的建立反相高效液相色谱(RP-HPLC)法测定人体血浆中氨磺必利的含量。方法色谱柱为美国DiamonsilR(250 mm×4.6 mm,5μm)C18反相柱;流动相为甲醇-乙腈-缓冲液(6 ml三乙胺加入1 000 ml水中,冰醋酸调pH值为6.8)=30∶50∶20,流速为1.1 ml/min;检测波长275 nm。结果氨磺必利血浆浓度在2.1～268.8 ng/ml范围内,线性关系良好,标准曲线为C=1.039 6 F-0.020 7(r=0.999 7,n=8),定量下限2.1 ng/ml。结论 RP-HPLC法具有快速、简便、灵敏度高、重现性好等优点,可以广泛用于氨磺必利临床研究和不良反应监测。
Objective To establish a reverse-phase high performance liquid chromatography (RP-HPLC) method for the determination of amisulpride in human plasma. Methods The column was a C18 reversed-phase column with Diamonsil R (250 mm × 4.6 mm, 5 μm). The mobile phase was methanol-acetonitrile-buffer (6 ml triethylamine was added to 1000 ml water and the pH was adjusted to 6.8 with glacial acetic acid) 30:50:20, flow rate of 1.1 ml / min; detection wavelength of 275 nm. Results The plasma concentration of amisulpride was in the range of 2.1-268.8 ng / ml with a good linearity. The standard curve was C = 1.039 6 F-0.020 7 (r = 0.999 7, n = 8) and the limit of quantification was 2.1 ng / ml. Conclusion RP-HPLC method has the advantages of fast, simple, high sensitivity and good reproducibility. It can be widely used in amisulpride clinical research and adverse reaction monitoring.