Rapid determination of gemifloxacin in human plasma by high-performance liquid chromatography–tandem mass spectrometry

Doyle, E.; Fowles, Susan; McDonnell, David; McCarthy, R.; White, Stephen

doi:10.1016/s0378-4347(00)00333-9

Cited by 54 publications

(39 citation statements)

References 5 publications

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“…11,14 Very few methods have been published for the quantification of gemifloxacin in plasma. A method was developed by Doyle et al 15 for the determination of gemifloxacin in human plasma using liquid chromatography-tandem mass spectrometry. Allen et al 16 have quantified concentrations of gemifloxacin in serum and urine by a reversedphase liquid chromatography (LC) method with fluorescence detection (SmithKline Beecham, unpublished data).…”

Section: Introductionmentioning

confidence: 99%

Retracted: Convulsant activity and pharmacokinetic–pharmacodynamic modeling of the electroencephalogram effect of gemifloxacin in rats

Roy

Bose

Bhaumik

et al. 2010

Journal of Pharmaceutical Sciences

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Section: Introductionmentioning

confidence: 99%

Retracted: Convulsant activity and pharmacokinetic–pharmacodynamic modeling of the electroencephalogram effect of gemifloxacin in rats

Roy

Bose

Bhaumik

et al. 2010

Journal of Pharmaceutical Sciences

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“…The data acquisition was done with RAD (version 2.6; PE Sciex, Thornhill, Ontario, Canada), and the data processing was done with MacQuan software (version 1.5; 1991 to 1997; Perkin-Elmer, Toronto, Ontario, Canada). The details of the method have been reported previously (6).…”

Section: Methodsmentioning

confidence: 99%

Urinary Excretion and Bactericidal Activities of Gemifloxacin and Ofloxacin after a Single Oral Dose in Healthy Volunteers

Naber

Hammer

Kinzig‐Schippers

et al. 2001

Antimicrob Agents Chemother

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In a randomized crossover study, 16 volunteers (8 men, 8 women) received single oral doses of 320 mg of gemifloxacin and 400 mg of ofloxacin on two separate occasions in the fasting state to assess the urinary excretion and urinary bactericidal titers (UBTs) at intervals for up to 144 h. Ofloxacin showed higher concentrations in urine compared with those of gemifloxacin. The median (range) cumulative excretion of gemifloxacin was 29.7% (8.4 to 48.7%) of the parent drug administered, and median (range) cumulative excretion of ofloxacin was 84.3% (46.5 to 95.2%) of the parent drug administered. The UBTs, i.e., the highest twofold dilutions (with antibiotic-free urine as the diluent) of urine that were still bactericidal, were determined for a reference strain and nine uropathogens for which the MICs of gemifloxacin and ofloxacin were as follows: Escherichia coli ATCC 25922, 0.016 and 0.06 g/ml, respectively; Klebsiella pneumoniae, 0.03 and 0.06 g/ml, respectively; Proteus mirabilis, 0.125 and 0.125 g/ml, respectively; Escherichia coli, 0.06 and 0.5 g/ml, respectively; Pseudomonas aeruginosa, 1 and 4 g/ml, respectively; Staphylococcus aureus, 0.008 and 0.25 g/ml, respectively; Enterococcus faecalis, 0.06 and 2 g/ml, respectively; Staphylococcus aureus, 0.25 and 4 g/ml, respectively; Enterococcus faecalis, 0.5 and 32 g/ml, respectively; and Staphylococcus aureus, 2 and 32 g/ml, respectively. Generally, the UBTs for gram-positive uropathogens were higher for gemifloxacin than for ofloxacin and the UBTs for gram-negative uropathogens were higher for ofloxacin than for gemifloxacin. According to the UBTs, ofloxacin-resistant uropathogens (MICs, >4 mg/liter) should also be considered gemifloxacin resistant. Although clinical trials have shown that gemifloxacin is effective for the treatment of uncomplicated urinary tract infections, whether an oral dosage of 320 mg of gemifloxacin once daily is also adequate for the treatment of complicated urinary tract infections has yet to be confirmed.The rationale for the use of an antimicrobial agent in the management of infectious diseases is its antibacterial activity at the site of the inflammatory process. In the case of urinary tract infection (UTI), the antibacterial spectrum of the antimicrobial agent should include not only Escherichia coli and other species of the family Enterobacteriaceae but also enterococci, staphylococci, and nonfermenting bacteria such as Pseudomonas and Acinetobacter spp. The fluoroquinolones, such as ciprofloxacin and ofloxacin or levofloxacin, which have broadspectrum antibacterial activities against most gram-negative uropathogens, and the more recent members of this class, which are active against gram-positive uropathogens, are recommended as first-line agents for the treatment of complicated and nosocomial UTIs.Gemifloxacin, a new fluoroquinolone, has a broad spectrum of activity in vitro against gram-negative bacteria such as E. coli, Proteus mirabilis, some strains of Pseudomonas aeruginosa, and Klebsiella pneumoniae, and against gram-positi...

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“…2,3 The drug is approved by FDA only for respiratory indications: acute bacterial exacerbation of chronic bronchitis and communityacquired pneumonia, including that caused by known or suspected multidrug resistant strains of S. pneumoniae, because it has good penetration into respiratory secretions, such as the epithelial lining fluid and into alveolar macrophages, with adequate concentrations at the site of the infection. 4,5 Although there are studies describing the determination of GFM in biological fluids by HPLC-MS, 6,7 HPLC-ESI-MS-MS, 8 HPLC and HPTLC 9 and in tablets by VIS spectrophotometry, 10,11 HPLC 12 and microbiological assay 13 there are no studies describing quantification methods by UV spectrophotometry. Then the main objective of this study was to develop a simple, fast and low cost UV spectrophotometry method, without extraction process, derivatization, evaporation step, and complexation agent, providing decrease in time and error in the quantitative determination of GFM in coated tablets.…”

Section: Gemifloxacin Mesylate (Gfm Figure 1) Chemically ((Rs)-7-[mentioning

confidence: 99%

Gemifloxacin mesylate: UV spectrophotometric method for quantitative determination using experimental design for robustness

et al. 2012

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Recebido em 4/2/11; aceito em 21/5/11; publicado na web em 26/7/11This study describes the validation of UV spectrophotometric method for quantitative determination of gemifloxacin mesylate (GFM) in tablets using methanol as solvent. The method was specific, linear, precise, exact and robust at 272 and 343 nm. The results confirmed that the method in both wavelengths is valid and useful to the routine quality control of GFM in coated tablets. The validate method was compared to liquid chromatography (HPLC), microbiological assay and visible (VIS) spectrophotometry, which were previously developed and validated to the same drug. There was not significative difference between the methods for GFM quantitation.

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Rapid determination of gemifloxacin in human plasma by high-performance liquid chromatography–tandem mass spectrometry

Cited by 54 publications

References 5 publications

Retracted: Convulsant activity and pharmacokinetic–pharmacodynamic modeling of the electroencephalogram effect of gemifloxacin in rats

Retracted: Convulsant activity and pharmacokinetic–pharmacodynamic modeling of the electroencephalogram effect of gemifloxacin in rats

Urinary Excretion and Bactericidal Activities of Gemifloxacin and Ofloxacin after a Single Oral Dose in Healthy Volunteers

Gemifloxacin mesylate: UV spectrophotometric method for quantitative determination using experimental design for robustness

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