高效液相色谱法测定人血浆中芦氟沙星血药浓度方法的改进?

HPLC Improvement on Determining Human Plasma Concentration of Rufloxacin

目的建立测定人血浆中芦氟沙星浓度的高效液相色谱法(HPLC),并应用于人体药动学研究。方法以左氧氟沙星为内标,待测血浆用二氯甲烷萃取后,采用PlastisilODS色谱柱(250mm×4.6mm,5μm),以0.057mol?L-1磷酸二氢钾缓冲溶液:乙腈[84:16,用磷酸调pH至(3.50±0.01)]为流动相,检测波长297nm,流速1.2ml/min。结果血浆中内源性物质不干扰测定;芦氟沙星在0.0250～5.0025μg?mL-1范围内线性关系良好,定量下限为0.0250μg?mL-1。提取回收率为68.6%～73.5%。结论该方法简便、准确、灵敏度高、专属性强,适用于人血浆中芦氟沙星的测定。

Objective To develop a HPLC method for determination of rufloxacin in human plasma. The pharmacokinetics in human was also investigated. Methods Plasma was extracted by dichloromethane using levofloxacin as internal standard and then separated on a Plastisil ODS（ 250ram × 4.6mm, 5μm ）column using 0.057 mol·L-1 potassium dihydrogen phosphate-acetonitrile（ 84：16, adjusted pH to 3.50 ± 0.01 with phosphoric acid ） as mobile phase. The detection wavelength was 297 nm. The flow rate was 1.2ml· min i. Results The assay had a calibration range from 0.0250 to 5.0025μg,mL-1 and lower limit of quantification （LLOQ） was 0.0257 μg,mL-1 for rufloxacirl. The recovery of rufloxacin was 75.6%-77.7%. Conclusion The method was shown to be simple, accurate, sensitive and specific which is suitable for determination of Rufioxacin in human plasma.