摘要
目的建立了血浆中左氧氟沙星的反相HPLC．uv测定法。方法C18反相柱，流动相：KH2P04水溶液：乙腈：庚烷磺酸钠溶液（img·mL-1）（100：25：6，v／v／v），流速：1mL·min-1；检测波长：295nm。以洛美沙星作为内标．庚烷磺酸钠作为离子对。结果色谱图良好．无拖尾等现象，血浆中内源性杂质T-干扰样品的援．1定，标准曲线线性范围为0．05p．g·mL-1-5肛g·mL-1，线性关系良好；高、中、低3种浓度的批间和枇内变异均小于10．0％；绝对回收率在75．3％～82．3％；符合生物样品分析要求。结论20名健康受试者口服左氧氟沙星两种制剂，对参数Cmax、AUC0-τ进行方差分析，双单侧t检验．Tmax非参数法进行检验，表明所研究的两种药物制剂生物等效。
OBJECTIVE A new determination method of Ofloxacin concentration in plasma by HPLC-UV was established. METHODS The mobile phase consisted of KH2PO4 solution： methanol： acetonitrile： （1-Heptanesulfonic Acid Sodium Salt, 1mg·mL- 1） （ 100 ： 25 ： 6）, the flow rate is 1mL·min- 1 ; and detection was at 295nm; Diazepam was used as internal standard, and 1-Heptanesulfonic Acid Sodium Salt was used as ion pair reagent. RESULTS The stablished method was linear in the range of 0.05-- 5μg·mL- 1, the RSD of precision is little than 10.0 %, and the absolute recovery was during 75.3 and 82.3 %, which is enough for the analysis of biological sample. CONCLUSION The comparison of the relative tablet and test tablet＇s Cmax, AUCO-, t-test, and Tmax that from 20 healthy volunteers indicates that the two form ulations were hioequivalent.
出处
《海峡药学》
2011年第10期204-206,共3页
Strait Pharmaceutical Journal
基金
广东省自然科学基金(10151052005000003)
广东省医学科研基金(B2009043)
