反相高效液相色谱法测定人血浆及尿液中甲磺酸帕珠沙星浓度

Determination of Pazufloxacin Mesilate Concentration in Human Plasma and Urine by RP-HPLC

目的:建立血浆及尿液中甲磺酸帕珠沙星浓度的反相高效液相色谱分析方法。方法:用甲醇沉淀血浆蛋白,离心后取上清液进行色谱分析;尿样稀释后离心取上清液进样。分析柱为DiamonsilC18,流动相为乙腈-0.05mol/L磷酸二氢钾(含1%四丁基溴化铵)(8∶92,V/V),流速为1.4ml/min,激发波长320nm,发射波长400nm。结果:甲磺酸帕珠沙星在血浆和尿液中的检测浓度线性范围均为31.25～10000ng/ml(r=0.9999);在血浆、尿液中的相对回收率分别为97.77%～99.87%、98.31%～100.82%,RSD<1.0%～3.0%。结论:本方法准确可靠、操作简便,适用于甲磺酸帕珠沙星的临床药动学及常规血药浓度监测。

OBJECTIVE：： To establish a RP- HPLC analytical method for the determination of pazufloxacin mesilate in human plasma and urine, METHODS： The plasma proteins were precipitated with methanol and the supernatant liquid obtained from the serum centrifugate was subjected to chromatographic analysis. The supernatant liquid obtained from the diluted urine centrifugate was subjected to sample introduction. The analytical column was Diamonsil C18, the mobile phase consisted of acetonitrile - 0.05 mol/L potassium dihydrogen phosphate （containing 1% tetrabutylammonium bromide） （8 ： 92, V/V） with a flow rate at 1.4 ml/min, excitation wavelength at 320nm and emission wavelength at 400 nm. RESULTS： The linear range of pazufloxacin mesilate in both plasma and urine was 31.25 --10 000 ng/ ml（r = 0.9 999） . The relative recoveries of pazufloxacin mesilate in human plasma and urine were 97.77% - 99.87% and 98.31% - 100.82%, respectively with RSD less than 1.0%- 3.0%. CONCLUSION： This method is accurate, reliable and simple and it is suitable for the pharmacokinetic study and routine monitoring of blood concentration of pazufloxacin mesilate.