人血浆中头孢克洛高效液相色谱法与微生物法测定

Determination of cefaclor in human plasma by high performance liquid chromatography and bioassay

目的:比较高效液相色谱法(HPLC)和微生物法测定头孢克洛血药浓度的差异。方法:10名健康受试者单剂量口服头孢克洛胶囊500mg,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0.125~16mg·L-1,回收率为(93.34±5.94)%^(96.80±4.38)%,日内、日间相对偏差(RSD)分别为4.17%~6.36%和5.64%~9.09%;微生物法线性范围为0.125~16mg·L-1,回收率为(93.21±5.80)%^(95.62±4.23)%,日内、日间RSD分别为4.17%~6.03%和6.57%~8.70%;2种方法测定的受试者平均血药浓度和主要药动学参数差异无统计学意义。结论:2种方法精密度和回收率基本一致,均可用于头孢克洛血药浓度的测定。

Aim： To compare high performance liquid chromatography （HPLC） and bioassay for determination of cefaclor in human plasma. Methods：Cefaclor were administreted to ten healthy volunteers with a single oral dose of 500 mg. Plasma concentrations were determined by the methods of HPLC and bioassay, respectively. Results： The linear range of HPLC was 0. 125 through 16 mg·L^-1 ,and the recovery of HPLC was （93.34 ± 5.94）% through （96.80 ± 4.38 ）% , within-day and day-to-day RSD were 4.17% to 6.36% and 5.64% to 9.09% ,respectively;the linear range of bioassay was 0. 125 to 16 mg·L^-1. The recovery of bioassay was （93.21±5.80）% to （95.62±4.23）% ,within-day and day -to-day RSD were 4.17% to 6.03% and 6.57% to 8.70% , respectively. There was no significant differences in cefaclor mean plasma concentrations and main pharmacokinetic parameters obtained by the methods of HPLC and bioassay. Conclusion ： The recovery and the precision of the both methods are similar, so both of them can be used to determinate the plasma concentrations of cefaclor.