HPLC测定血浆中福辛普利的活性代谢物福辛普利拉浓度

HPLC Determination of Fosinoprilat——Active Metabolite of Fosinopril in Human Plasma

目的 :建立人血浆中福辛普利拉HPLC测定法 ,为血药浓度监测和临床合理用药提供方法学基础。方法 :血浆样品酸化后用乙醚 -二氯甲烷混合溶媒提取 ,以双氯芬酸钠为内标 ,流动相为甲醇 - 10mmol·L- 1 磷酸氢二钾溶液 (内含 5mmol·L- 1 氯化四丁基铵 ) (6 8∶32 ) ,磷酸调pH至 7 6 ;流速为 1 0mL·min- 1 ;检测波长 2 10nm。结果 :本法在 10 5～ 1112 0ng·mL- 1 范围内线性良好 ,r=0 9988。高中低浓度的 3个质控样品日内RSD <8 12 % ,日间RSD <8 10 % ,本法的相对误差 <13 4%。血浆最低检测浓度为 10 5ng·mL- 1 。结论 :本法快速、准确、重现性好 ,适用于该药物临床血药浓度监测。

Objective:To establish a HPLC assay method for the determination of fosinoprilat in human plasma.Method:A reversed phase ion-pair chromatographic method has been developed after the plasma samples having been extracted by ether-dichloromethane mixed solvent.Column:Hypersil ODS,5 μm,25 cm×46 mm;Mobile phase:Methanol-10 mmol·L -1 di-potassium hydrogen phosphate consisting of 5 mmol·L -1 tetra-butyl ammonium chloride(68∶32),pH was adjusted to 76 with phosphoric acid;Flow rate:10 mL·min -1;Detection wavelength:210 nm.Results:Assay linearity was obtained in the range of 105～1 1120 ng·mL -1;intra- and inter-day precisions were lower than 812% and 810%,respectively;relative error of the method was lower than 134%;the lowest detectable concentration was 105 ng·mL -1.Conclusion:The improved method is rapid,accurate and reproducible.It is suitable for therapeutic drug monitoring(TDM).