反相高效液相色谱法测定卡德沙星在健康人体的血药浓度

Determination of caderofloxacin concentration in healthy human plasma by RP-HPLC

目的建立反相高效液相色谱法测定人血浆中卡德沙星(喹诺酮类抗菌药)浓度的方法。方法以加替沙星为内标,血浆样品经6%高氯酸沉淀,梯度洗脱,检测波长286nm。结果卡德沙星在0.1～10.0mg·mL-1内线性关系良好,相对回收率为96.41%～109.52%,日内、日间RSD均小于15%;在2名中国健康受试者3h恒速静滴卡德沙星400mg后,其药代动力学符合开放二房室模型,主要药代动力学参数:Cmax=3.42、6.04mg·mL-1,t1/2β=7.74、6.73h,AUC0-t=32.35、28.26mg·h·L-1。结论此方法准确、灵敏度高、专属性强,适用于临床药代动力学研究。

Objective To establish a sensitive and specific RP-HPLC method for determination caderofloxacin concentration in healthy human plasma. Methods Human plasma with internal standard was precipitated by perchloric acid. The separation was analyzed in gradient elution system and the detection wave was 286 nm. Results The linear range of pseudoephedrine was 0. 1 - 10.0 mg·L^-1. The relative recovery were within 96.41% - 109.52%. The within - day and the between day RSD were all less than 15 %. After single infusion cadero-floxacin of 400 mg/3 h in two healthy volunteers. It was found to be fitted to a two - compartment open model and its pharmacokinetic parameters were as follows： Cmax was 3. 39,4. 04 mg·L^-1, AUC0-t was 32.35,28.26 mg·h·L^-1, t1/2a was 7. 74,6. 73 h, respectively. Conclusion The method is accurate, convenient, sensitive, specific, and was suitable for the study of clinical pharmacokinetics.