Validation of an HPLC method for the determination of ciprofloxacin in human plasma

被引:71
作者
Imre, S
Dogaru, MT
Vari, CE
Muntean, T
Kelemen, L
机构
[1] Univ Med & Pharm, Fac Pharm, Targu Mures 4300, Romania
[2] ARMEDICA SA, Dept Drug Dev, Targu Mures 4300, Romania
关键词
ciprofloxacin; reversed-phase HPLC; pharmacokinetics;
D O I
10.1016/S0731-7085(03)00151-1
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A simple HPLC method with fluorescence detection of ciprofloxacin in human plasma was developed and validated. After protein precipitation, chromatographic separation of ciprofloxacin in plasma was achieved at 35 degreesC with a C18 column and acetonitrile-phosphate mixture, pH 3, as mobile phase. Quantitative determination was performed by fluorimetry after excitation at 278 nm. The method was specific and validated with a limit of quantification of 41 ng/ml. The intra- and inter-day coefficients of variation were between 0.5 and 6.6% and accuracy between -2.02 and 7.04%. Ciprofloxacin was stable in plasma for 40 days at -20 degreesC and after three freezing-thawing cycles. The method has been applied in a bioequivalence study of two formulation of 500 mg ciprofloxacin. (C) 2003 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:125 / 130
页数:6
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