生物法和HPLC测定左氧氟沙星血药浓度的比较

 目的：建立用生物法和HPLC测定左氧氟沙星血药浓度的方法，为临床合理用药提供依据。方法：生物法使用培养基Ⅱ号和金葡球菌。HPLC用300g·L^-1三氯醋酸沉淀蛋白，流动相为甲醇0.02mol·L^-1-磷酸二氢钾溶液（3∶7，1mol·L^-1磷酸调节pH＝3.0），检验波长290nm．结果：生物法测定不同浓度左氧氟沙星的平均回收率在95.90％～106.68％范围内，日内和日间RSD低于6％。HPLC测定不同浓度左氧氟沙星的平均回收率在97.24％～101.70％范围内，日内和日间RSD低于5％。6例患者以两种方式po左氧氟沙星片剂后，用生物法和HPLC测其血药浓度，结果经方差分析及t检验分析，无显著性差异（P＞0.05）。结论：生物法价廉、省时、结果准确可靠；HPLC灵敏度高、分析速度快、分离效果好。这两种方法可以根据具体的实验条件选用。

Comparison of bioassay and HPLC for the determination of levofloxacin in plasma

OBJECTIVE:The bioassay and HPLC methods were established and compared for the determination of levofloxacin(Lev) in human plasma.METHOD:In bioassay,medium Ⅱ and staphylococcus aureus were used.The HPLC method was chromatographed with a mobile phase of methanol-0.02mol/L potassium dihydrogen phosphate solution (3∶7)，the sample was treated by adding 30% trichloroacetic acid to precipitate protein,and detected at 276mm.RESULTS:The average recovery of bioassay was within 95.90%～106.68%,the within-day and day-to-day precisions were below 6%.The average recovery of HPLC was within 97.24%～101.70%,the within day and day-to-day precisions were blow 5%.Lev tablets were given to 6 patients in two ways.Drug concentrations in plasma were determined by bioassay and HPLC assay,respectively,with no significant difference (P＞0.05).CONCLUSION:The bioassay was simple,cheap,time saving,and reliable.The HPLC method wsa rapid,sensitive,accurate.The two methods may be selected to use in actual conditions.