Validated microbiological and HPLC methods for the determination of moxifloxacin in pharmaceutical preparations and human plasma

Brazilian Journal of Microbiology

Ahmed A. Abdelaziz¹  Tarek E. Elbanna¹  Noha M. Gamaleldeen¹ 

[1] ,University of Tanta Faculty of Pharmacy Department of Pharmaceutical MicrobiologyTanta,Egypt

关键词: Moxifloxacin;    Microbiological assay;    HPLC assay;    Pharmaceutical analysis;    Pharmacokinetics;   

DOI  :  10.1590/S1517-83822012000400008

来源: SciELO

【 摘 要 】

The article presents a comparison between microbiological and high performance liquid chromatographic (HPLC) assays for quantification of moxifloxacin in tablets, ophthalmic solutions and human plasma. The microbiological method employed a cylinder-plate agar diffusion assay using a strain of Esherichia coli ATCC 25922 as the test organism and phosphate buffer (pH8) as the diluent. The calibration curves were linear (R²> 0.98) over a concentration range of 0.125 to 16 µgml-1. The within day and between days precisions were < 4.47% and < 6.39% respectively. Recovery values were between 89.4 and 110.2%. The HPLC assay used Hypersil® BDS C18 reversed phase column (250×4.6 mm, 5µm) with a mobile phase comprising 20 mM ammonium dihydrogen orthophosphate (pH3) and acetonitrile (75:25) and flowing at 1.5 ml/min. The detection was at 295nm. The calibration curves were linear (R²> 0.999) over the range of 0.125 to 16 µg ml-1. The within day and between days precisions were < 4.07% and < 5.09% respectively. Recovery values were between 97.7 and 107.6%. Similar potencies were obtained after the analysis of moxifloxacin tablets and ophthalmic solutions by both methods. Also pharmacokinetic parameters were calculated after the analysis of plasma samples of six male healthhy volunteers by both validated methods.

【 授权许可】

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