高效液相色谱法与微生物法测定人血浆中氧氟沙星浓度的比较

目的 :比较高效液相色谱法 (HPLC)和微生物法测定氧氟沙星血药浓度。方法 :8名健康受试者单剂量静脉滴注氧氟沙星注射液 2 0 0mg ,分别用HPLC法和微生物法测定血浆中药物浓度。结果 :HPLC法线性范围为 0 .12 5～ 5mg·L- 1,回收率为 (93±s 5 ) %～ (10 6± 7) % ,日内、日间相对标准差 (RSD)分别为 3.9%～ 7.4 %和 3.0 %～ 7.7% ;微生物法线性范围为 0 .12 5～ 5mg·L- 1,回收率为(99± 3) %～ (10 7± 6) % ,日内、日间RSD分别为2 .8%～ 3.9%和 3.4 %～ 8.0 %。受试者平均血药浓度和主要药动学参数差异无显著性。结论 :2种方法精密度和回收率基本一致 ,均可用于氧氟沙星血药浓度的测定

Comparison of high performance liquid chromatography and bioassay for determination of ofloxacin in human plasma

AIM:To compare high performance liquid chromatography(HPLC) and bioassay for determination of ofloxacin in human plasma. METHODS: Ofloxacin injections were given to eight healthy volunteers with a single dose, iv, drip, 200 mg. Plasma concentrations were determined by HPLC method and bioassay, respectively. RESULTS: The calibration curve of HPLC method was linear in the range of 0.125 5 mg·L -1 . The recovery of HPLC was within (93± s 5) % and (106±7) %, within day and day to day RSD were 3.9 % 7.4 % and 3.0 % 7.7 %. The calibration curve of bioassay was linear in the range of 0.125 5 mg·L -1 . The recovery of bioassay was within (99±3) % and (107±6) %, within day and day to day RSD were 2.8 % 3.9 % and 3.4 % 8.0 % . There was no significant difference in ofloxacin mean plasma concentrations and main pharmacokinetic parameters obtained by HPLC method and the bioassay. CONCLUSION: The recovery and the precision of the both methods were found to be similar, therefore both can be used to determinate plasma concentrations of ofloxacin.