高效液相色谱法测定血清中甲磺酸帕珠沙星的浓度

Determination of pazufloxacine mesylate in human plasma by HPLC

目的：建立人血清中甲磺酸帕珠沙星的高效液相色谱检测方法。方法：采用C18色谱柱（4．6mm×150mm，5μm）；柱温：室温；流动相：0．04mol·L^-1磷酸-乙腈-三乙胺（87：13：0．5，pH3．3）；流速：1．0mL·min^-1；内标：奥硝唑；检测波长：248nm。结果：甲磺酸帕珠沙星在1.0～15．0mg·L^-1范围内线性关系良好（r=0．9998，n=6），平均提取回收率为85.24％，RSD为2．59％，方法回收率为97．47％，RSD为0．76％，日内RSD为4．88％，日间RSD为7．12％。结论：该方法快速、准确、灵敏度高、专一性强，可用于甲磺酸帕珠沙星血清浓度监测和药动学及生物利用度研究。

OBJECTIVE To develop a reversed-phase HPLC method for the determination of pazufloxacine mesylate in human serum. METHODS The column temperature was maintained at ambient temperature, 0. 04 mol·L^-1 phosphate-acetonitrile-triethylamide （87：13 ： 0. 5） as mobile phase was pumped at a flow-rate of 1.0 mL· min^-1. The internal standard was ornidazole. The detective wavelength was 240 nm. RESULTS RESULTS The linear relationship was excellent over the range of 1.0 - 15. 0 mg·L^-1 （r= 0. 999 8,n = 6）. The extracting recovery was 85.24% ,RSD was 2. 59% ,while method recovery was 97. 47%,RSD was 0. 76%. The wlthin-day and between days RSD were 4. 88% and 7. 12% respectively. CONCLUSION The elaborated method is rapid, sensitive, precise and selective, and can be used for determination of pazufloxacine mesylate in serum in therapeutic drug monitoring and pharmacokinetic studies.