RP-HPLC测定人尿液中甲磺酸帕珠沙星的浓度

目的 建立测定甲磺酸帕珠沙星的尿药浓度的方法,计算累积尿药排泄率.方法 采用反相高效液相色谱（RP-HPLC）法,色谱柱为C18柱（4.6 mm×150 mm,5μm）,柱温35℃;流动相：乙腈-甲醇-水（6∶12∶82,含0.01％磷酸和0.01％三乙胺）;流速：1.10 ml/min;检测波长：245 nm.结果 甲磺酸帕珠沙星最低定量浓度为13.6 μg/ml;尿药标准曲线线性范围为13.6～2720 μg/ml （r=0.9997）,方法回收率＞90％;日内、日间精密度（RSD）＜10.0％.30名健康志愿者进行单剂量静脉注射低、中、高三种剂量的注射用甲磺酸帕珠沙星后,帕珠沙星在24 h内尿液中的累积尿药排泄率分别为（92.63±5.04）％、（91.21±2.09）％、（90.22±3.53）％.结论 该方法快速、简便、准确度高,专属性好,无杂质干扰,适用于帕珠沙星体内药物浓度的测定及药代动力学研究.

Determination of pazufloxacin mesilate in human urine by RP-HPLC

Objective To establish a method to determine the urine concentration of pazufloxacin mesilate and calcu- late cumulative urinary excretion rate.Methods Reversed phase high performance liquid chromatography （RP-HPLC） was established,the column was Cts （4.6 mm150 mm,5 μm）,column temperature was 35C,with acetonitrile-methanol-water （0.01% H3PO4 and 0.01% triethyamin） of 6：12：82 as the mobile phase.The flow rate was 1.10 ml/min.The detection wavelength was 245 nm.Results The calibration curve was linear in the range of 13.6 to 2720 pg/ml （r=0.9997） for pazu- floxacin.The methodology recoveries was higher than 90% for the anahytes.The RSD value of within-day and between- day was less than 10.0%.After being given an iv administration of single dose including low,medium and high of pazu- floxacin mesilate,the accumulative urine exeretion rate of 30 volunteers during 24 h was （92.63＋_5.04）%,（91.21_＋2.09）%, （90.22＋3.53）% respectively.Conclusion The method is accurate,sensitive,specific and reliable for pazufloxacin,and the impurities do not interrupt.It may be applied to study drug concentration and pharmacokinetic.