反相高效液相色谱法测定氨氯地平血药浓度

Reversed Phase HPLC Determination of Amlodipine in Human Plasma

目的 建立反相高效液相色谱法 ( HPLC)测定人血浆中氨氯地平浓度。 方法 血浆样品用重蒸馏乙醚提取 ,以达克罗宁为内标 ;甲醇 -0 .0 3 mol· L- 1磷酸二氢钾缓冲液 ( 72∶ 2 8)为流动相 ,流速 1.0 ml·min- 1 ;检测波长 2 3 8nm;柱温 :室温。 结果 本法在 1.0～ 12 .0 ng·m L- 1范围内线性关系良好 ,r=0 .9980。日内 RSD为 3 .7%～ 6.7% ( n=5 ) ,日间 RSD为 6.0 %～ 7.1% ( n=15 ) ;回收率 89.0 %～ 10 1.7% ;血清最低检测浓度为 0 .15 ng·m L- 1 ( S/N=2 )。 结论 本法灵敏、准确、快速 ,为该药物的临床血药浓度监测和药代动力学研究提供依据。

OBJECTIVE To establish a HPLC assay method for the determination of Amlodipine in human plasma.METHODS A reversed phase chromatographic method was developed after the plasma samples were extracted by redistilled ether solvent.HPLC conditions were set as follows:Columm:Lichro CART C18,250mm×4mm,5μm;Mobile phase methanol-0.03mol·L -1 Potassium Dihydrogen Phosphate(72∶28);Flow rate:1.0ml·min -1 ,Detection wave length:238nm.Column temperature:room termperature.RESULTS Assay linearity was obtained in the range of 1.0～12.0ng·mL -1 ;Intraday and interday RSD were 3.7%～6.7%(n=5)and 6.0%～7.1%(n=15),respectively.Recovery was 89.0%～101.7%;The lowest detectable concentration was 0.15ng·mL -1 (S/N=2).CONCLUSION The method is sensitive accurate and rapid.It is suitable for therapeutic drug monitoring(TDM).