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目的:建立反相高效液相色谱法检测人血浆中辛伐他汀。方法:应用OASIS固相萃取注柱提取血浆中辛伐他汀,采用反相高效液相色谱法二极管阵列检测器检测,色谱柱为Symmetry C18柱(250mm×4.6mm,5m),内标物为洛伐他汀,流动相为0.1%磷酸液(用氢氧化钠调致pH4.5)-乙腈30:70,检测波长254nm,流速1.2ml.min-1。结果:辛伐他汀在1.0~40.0ng.ml-1范围内线性良好(r=0.9998)。低、中、高浓度加样回收率在98%~104.0%之间,日内、日间RSD在5.8%~8.6%之间,最低检测浓度为0.8ng.ml-1。结论:本法快速、灵敏、高效,适于辛伐他汀的血药浓度检测。
Objective: To establish a reversed-phase high performance liquid chromatography for the determination of simvastatin in human plasma. Methods: Simvastatin was extracted by OASIS column and was detected by reversed-phase high performance liquid chromatography with diode array detector. The column was Symmetry C18 column (250 mm × 4.6 mm, 5 μm) The statin, the mobile phase 0.1% phosphoric acid solution (adjusted to pH 4.5 with sodium hydroxide) -acetonitrile 30:70, detection wavelength 254nm, flow rate 1.2ml.min-1. Results: Simvastatin was linear over the range of 1.0-40.0 ng.ml-1 (r = 0.9998). The recoveries of low, medium and high concentration samples ranged from 98% to 104.0%. The intra-day and inter-day RSD values ranged from 5.8% to 8.6% with the lowest detection concentration of 0.8 ng.ml-1. Conclusion: The method is rapid, sensitive and efficient and suitable for the determination of simvastatin.