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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 method for the determination of fosinopril in human plasma, and to provide a methodological basis for the monitoring of plasma concentration and clinical rational drug use. Methods: After the plasma samples were acidified, they were extracted with a mixture of diethyl ether and methylene chloride. Diclofenac sodium was used as the internal standard and the mobile phase consisted of methanol-10 mmol·L-1 potassium phosphate dibasic solution (containing 5 mmol·L -1 tetrabutylphosphonium chloride Ammonium hydroxide) (6:32:32), adjusting the pH to 7 6 with phosphoric acid; the flow rate was 10 mL · min -1; the detection wavelength was 210 nm. Results: The method was linear in the range of 10 5 ~ 11 12 0 ng · mL -1, r = 0 9988. RSD <8 12%, daytime RSD <8 10%, and relative error <13 4% of the three high quality control samples were low. The lowest plasma concentration of 10 5 ng · mL-1. Conclusion: The method is rapid, accurate and reproducible. It is suitable for the clinical monitoring of blood concentration of the drug.