title: validated microbiological and HPLC methods for the determination of moxifloxacin in pharmaceutical preparations and human plasma.
abstract: 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 (R(2) > 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 (R(2) > 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.
authors.affiliation: Department of Pharmaceutical Microbiology, Faculty of Pharmacy , University of Tanta, Tanta , Egypt.
authors.forename: Ahmed A
authors.initials: AA
authors.lastname: Abdelaziz
authors.forename: Tarek E
authors.initials: TE
authors.lastname: Elbanna
authors.forename: Noha M
authors.initials: NM
authors.lastname: Gamaleldeen
keywords: HPLC assay; Microbiological assay; Moxifloxacin; Pharmaceutical analysis; Pharmacokinetics
references.citation: J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Apr 15;877(11-12):1205-8
references.pmid: 19286427
references.citation: J Chromatogr B Analyt Technol Biomed Life Sci. 2004 Oct 15;810(1):77-83
references.pmid: 15358310
references.citation: J Pharm Biomed Anal. 2001 May;25(2):197-203
references.pmid: 11275428
references.citation: Antimicrob Agents Chemother. 1998 Aug;42(8):2060-5
references.pmid: 9687407
references.citation: J Chromatogr B Biomed Sci Appl. 1998 Sep 25;716(1-2):325-34
references.pmid: 9824247
references.citation: J Chromatogr B Analyt Technol Biomed Life Sci. 2002 May 25;772(1):53-63
references.pmid: 12016015
references.citation: Antimicrob Agents Chemother. 1991 Dec;35(12):2558-61
references.pmid: 1810189
references.citation: Int J Antimicrob Agents. 2008 Jan;31(1):21-6
references.pmid: 18054465
references.citation: J AOAC Int. 2005 Jul-Aug;88(4):1086-92
references.pmid: 16152924
references.citation: Curr Opin Pharmacol. 2001 Oct;1(5):459-63
references.pmid: 11764770
references.citation: J Pharm Biomed Anal. 2009 Sep 8;50(2):117-26
references.pmid: 19464135
references.citation: J Chromatogr B Biomed Sci Appl. 2001 Aug 25;760(1):91-5
references.pmid: 11522070
references.citation: Surv Ophthalmol. 2005 Nov;50 Suppl 1:S7-15
references.pmid: 16257313
references.citation: J Antimicrob Chemother. 1989 Sep;24(3):437-45
references.pmid: 2808195
references.citation: J Pharm Biomed Anal. 2007 Jan 4;43(1):320-4
references.pmid: 16872782
references.citation: J Pharm Biomed Anal. 2010 May 1;52(1):110-3
references.pmid: 20045276
references.citation: Drugs. 1999 Mar;57(3):363-73; discussion 374
references.pmid: 10193688
references.citation: Spectrochim Acta A Mol Biomol Spectrosc. 2007 Oct;68(2):250-6
references.pmid: 17329154
references.citation: Spectrochim Acta A Mol Biomol Spectrosc. 2009 Feb;72(1):138-43
references.pmid: 18977686