高效液相色谱法和微生物法测定人血浆中头孢克罗浓度的比较

Comparison of high performance liquid chromatography with bioassay for the determination of cefaclor in human plasma

目的 :比较HPLC法和微生物法测定头孢克罗血药浓度。方法 :8名健康志愿者单剂量口服 75 0mg头孢克罗胶囊 ,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 .2 5～ 2 5 .0 μg·ml-1,回收率为 (93.6～10 5 .7) % ,日内日间RSD分别为 (3.12～ 8.97) %和 (3.13～ 10 .6 6 ) % ;微生物法线性范围为 0 .1～ 2 .0 μg·ml-1,回收率为(92 .6～ 99.1) % ,日内日间RSD分别为 (6 .75～ 10 .87) %和 (5 .37～ 11.5 5 ) %。结论 :两种方法回收率和精密度基本一致 。

OBJECTIVE:Two methods for determination of cefaclor in human plasma were compared.METHODS:Cefaclor capsules were given to 8 healthy volunteers with a single oral dose of 750 mg.Plasma concentrations were determined by HPLC method and bioassay respectively.RESULTS:The calibration curve of HPLC method was linear in the range of 0.25 ～ 25.0 μg·ml -1 .The recovery of HPLC method was within 93.6% and 105.7% ,within day and day to day RSD were ( 3.12 ～ 8.97 )% and ( 3.13 ～ 10.66 )%.The calibration curve of bioassay was linear in the range of 0.1 ～ 2.0 μg·ml -1 .The recovery of bioassay was within 92.6% and 99.1% ,within day and day to day RSD were ( 6.75 ～ 10.87 )% and ( 5.37 ～ 11.55 )%.CONCLUSIONS:The recovery and the precision of these methods were found to be similar.There were no significant difference in cefaclor plasma concentrations and main pharmacokinetic parameters obtained by HPLC method and by the bioassay.