摘要
建立了HPLC-荧光法测定人血浆中的甲苯磺酸妥舒沙星,以加替沙星为内标,血浆样品萃取后经C18色谱柱分离,流动相为乙腈-甲醇-0.05mol/L磷酸二氢钾溶液(pH6.5)(10:30:60),荧光激发波长350nm,发射波长420nm。血浆中妥舒沙星在18.2～2280ng/ml浓度范围内线性关系良好,方法回收率为93.7%～104.1%,日内、日间RSD不大于10.1%和9.4%。18名健康志愿者采用随机交叉方式分别单剂量口服甲苯磺酸妥舒沙星分散片(受试制剂)或片剂(参比制剂)0.3g,AUC0→24h为(6403.0±1827.4)和(6544.1±1937.9)ng·h·ml-1,cmax为(1266.9±409.6)和(1258.2±395.8)ng/ml,tmax为(0.9±0.3)和(1.0±0.3)h。受试制剂的相对生物利用度为(98.6±7.4)%。
An HPLC-fluorescence method was established for the determination of tosufloxacin tosylate in human plasma. A C18 column was used with the mobile phase acetonitrile-methanol-0.05 mol/L potassium dihydrogen phosphate solution（pH 6.5） （10 ： 30 ： 60） and gatifloxacin as the internal standard. It was detected at excitation wavelength of 350 nm and the emission wavelength of 420 nm. The calibration curve was linear in the concentration range of 18.2 - 2 280 ng/ml. The method recovery was 93.7% - 104.1% with the inter- and intra-day RSDs no more than 10.1% and 9.4%. A single oral dose of 0.3 g tosufloxacin tosylate dispersible tablets （test preparation） and tablets （reference preparation） was administered to 18 healthy volunteers according to a randomized crossover study. The main pharmacokinetic parameters of test and reference preparations were as follows： A UC0-24h （6 403.0±1 827.4） and （6 544.1±1 937.9） ng.h.ml -1, Cmax（1 266.9±409.6） and （1 258.2±395.8） ng/ml, tmax （0.9±0.3） and （1.0±0.3） h. The relative bioavailability of test preparation was （98.6±7.4） %.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2010年第6期444-447,共4页
Chinese Journal of Pharmaceuticals
