Microbiological assay for enrofloxacin injection

Souza, Marinês Jost e; Bittencourt, Celso Figueiredo; Filho, P.

doi:10.1016/j.ijpharm.2003.11.012

Cited by 15 publications

(10 citation statements)

References 5 publications

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“…Consequently, if enro C becomes available at a commercial level, its rate of biotransformation into ciprofloxacin and other metabolites would require definition. Pharmacokinetics of enrofloxacin and sometimes its metabolites in broiler chickens have been previously defined by means of HPLC (Anadon et al ., ; Gberindyer et al ., ), and pharmacokinetic studies based on bioassay determination of enrofloxacin differ minimally from HPLC results (Abd el‐Aziz et al ., ; Ganiere et al ., ; Souza et al ., ). In this study, compliance between both methods to determine serum concentrations of enrofloxacin in spiked broiler serum samples showed an error not >6.2%.…”

Section: Discussionmentioning

confidence: 97%

“…In this study, compliance between both methods to determine serum concentrations of enrofloxacin in spiked broiler serum samples showed an error not >6.2%. Considering the above and given the importance to determine the concentration/activity of enrofloxacin from both, enro R and particularly enro C , due to its chemical manipulation, quantification of enrofloxacin was carried out in all serum samples by means of a bioassay (Souza et al, 2004;., Sumano et al, 2001). Additionally, it is worth noticing that serum concentrations of enro R , in this study, were very much in agreement with other values reported in literature (Anadon et al, 1995;Abd el-Aziz et al, 1997;Gberindyer et al, 2010), further validating the profiles determined for both enro C and enro R .…”

Section: Discussionmentioning

confidence: 99%

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Physicochemical characterization and pharmacokinetics in broiler chickens of a new recrystallized enrofloxacin hydrochloride dihydrate

Gutiérrez¹,

Miranda-Calderón²,

García-Gutiérrez

et al. 2014

Vet Pharm & Therapeutics

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Enrofloxacin, a key antimicrobial agent in commercial avian medicine, has limited bioavailability (60%). This prompted its chemical manipulation to yield a new solvate-recrystallized enrofloxacin hydrochloride dihydrate entity (enroC ). Its chemical structure was characterized by means of mass spectroscopy, Fourier transformed infrared spectroscopy, X-ray powder diffraction, and thermal analysis. Comparative oral pharmacokinetics (PK) of reference enrofloxacin (enroR ) and enroC in broiler chickens after oral administration revealed noticeable improvements in key parameters and PK/PD ratios. Maximum serum concentration values were 2.61 ± 0.21 and 5.9 ± 0.42 μg/mL for enroR and enroC , respectively; mean residence time was increased from 5.50 ± 0.26 h to 6.20 ± 0.71 h and the relative bioavailability of enroC was 336%. Considering Cmax /MIC and AUC/MIC ratios and the MIC values for a wild-type Escherichia coli O78/H12 (0.25 μg/mL), optimal ratios will only be achieved by enroC (Cmax /MIC = 23.6 and AUC/MIC = 197.7 for enroC ; vs. Cmax /MIC = 10.4 and AUC/MIC = 78.1 for enroR ). Furthermore, enroC may provide in most cases mutant prevention concentrations (Cmax /MIC ≥ 16). Ready solubility of powder enroC in drinking water at concentrations regularly used (0.01%) to provide an additional advantage of enroC in the field. Further development of enroC is warranted before it can be recommended for clinical use in veterinary medicine.

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Section: Discussionmentioning

confidence: 97%

Section: Discussionmentioning

confidence: 99%

Physicochemical characterization and pharmacokinetics in broiler chickens of a new recrystallized enrofloxacin hydrochloride dihydrate

Gutiérrez¹,

Miranda-Calderón²,

García-Gutiérrez

et al. 2014

Vet Pharm & Therapeutics

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“…Several analytical methods have been reported to quantify the concentration of API. They can be classified as microbiological assays (bioassay) [ 13 , 14 ], automated physicochemical assays (i.e. high performance liquid chromatography, HPLC) [ 15 ], and immunological assays (i.e.…”

Section: Introductionmentioning

confidence: 99%

Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibiotics

et al. 2009

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Background: Demonstration of equivalent amounts of the same active pharmaceutical ingredient (API) between generic and innovator products (pharmaceutical equivalence) is a basic requirement of regulatory agencies for intravenous generic drugs prior to clinical use, and constitutes the pivotal point to assume therapeutic equivalence. Physicochemical methods are preferred instead of biological assays to determine concentration of drugs in biological fluids, but it does not permit direct quantification of potency. Here, we report a microbiological assay using large plates designed to determine potency and concentration of pharmaceutical-grade antibiotics for injection and a statistical method to assess the in vitro equivalence of generic products with respect to the innovator.

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“…3 Although many chromatographic methods have been reported for the determination of fluoroquinolones, [4][5][6][7][8] just few methods have been found in the literature for determination of fluoroquinolones in pharmaceutical formulations using spectrophotometry 9,10 and bioassay. [11][12][13][14] More specifically, few reports about analytical methods of gatifloxacin in pharmaceutical formulations are available in the literature. [15][16][17][18][19][20][21] In this paper, the results of three methods is compared with respect to accuracy, precision and speed.…”

mentioning

confidence: 99%

Performance characteristics of bioassay UV-spectrophotometry and high perfomance liquid chromatographic determination of gatifloxacin in tablets

Oliveira¹,

Salgado²

2008

Quím. Nova

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Recebido em 13/4/07; aceito em 7/3/08; publicado na web em 22/9/08The microbiological bioassay, UV-spectrophotometry and HPLC methods for assaying gatifloxacin in tablets were compared. Validation parameters such as linearity, precision, accuracy, limit of detection and limit of quantitation were determined. Beer's law was obeyed in the ranges 4.0-14.0 µg/mL for HPLC and UV-spectrophotometric method, and 4.0-16.0 µg/mL for bioassay. All methods were reliable within acceptable limits for antibiotic pharmaceutical preparations being accurate, precise and reproducible. The bioassay and HPLC are more specific than UV-spectrophotometric analysis. The application of each method as a routine analysis should be investigated considering cost, simplicity, equipment, solvents, speed, and application to large or small workloads.

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Microbiological assay for enrofloxacin injection

Cited by 15 publications

References 5 publications

Physicochemical characterization and pharmacokinetics in broiler chickens of a new recrystallized enrofloxacin hydrochloride dihydrate

Physicochemical characterization and pharmacokinetics in broiler chickens of a new recrystallized enrofloxacin hydrochloride dihydrate

Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibiotics

Performance characteristics of bioassay UV-spectrophotometry and high perfomance liquid chromatographic determination of gatifloxacin in tablets

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