Quantitative determination of besifloxacin, a novel fluoroquinolone antimicrobial agent, in human tears by liquid chromatography–tandem mass spectrometry

Arnold, Dana R; Granvil, Camille; Ward, Keith W.; Proksch, Joel W.

doi:10.1016/j.jchromb.2008.03.025

Cited by 35 publications

(20 citation statements)

References 15 publications

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“…16 For animal tissues and plasma, quantitative bioanalysis was accomplished using HPLC/MS/MS methods following extraction of all samples with methanol. The HPLC system consisted of Shimadzu pumps (Shimadzu Co., Columbia, MD), an online vacuum degasser, a column temperature controller (Shimadzu Co.), and a CTC HTC PAL autosampler (LEAP Technologies, Carrboro, NC).…”

Section: Bioanalysismentioning

confidence: 99%

Ocular Pharmacokinetics of Besifloxacin Following Topical Administration to Rabbits, Monkeys, and Humans

Proksch¹,

Granvil

Siou-Mermet

et al. 2009

Journal of Ocular Pharmacology and Therapeutics

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Section: Bioanalysismentioning

confidence: 99%

Ocular Pharmacokinetics of Besifloxacin Following Topical Administration to Rabbits, Monkeys, and Humans

Proksch¹,

Granvil

Siou-Mermet

et al. 2009

Journal of Ocular Pharmacology and Therapeutics

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“…The purpose of this proposed work was to develop and validate the method using ultraviolet-high performance liquid chromatographic (UV-HPLC) for quantification of besifloxacin hydrochloride. In literature, other analytical methods described for the quantitative analysis of besifloxacin hydrochloride but no report found using UV-HPLC method [3][4][5][6][7][8][9]. The newly developed method was a unique advantage over the other available methods, as it is simple, accurate, precise, and specific for quantitative determination of besifloxacin hydrochloride in pharmaceutical dosage form.…”

Section: Introductionmentioning

confidence: 99%

Uv-HPLC Method Development and Validation for Quantification of Besifloxacin Hydrochloride

Saha

Patel

Halder

2017

Asian J Pharm Clin Res

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Objective: The objective of this investigation was to develop and validates a new, rapid, accurate high performance liquid chromatographic (HPLC) method for the quantification of besifloxacin hydrochloride. Materials and Methods:Isocratic ultraviolet (UV)-HPLC separation was performed using a Zodiac C18 (150 mm × 4.6 mm) column, with 150 volume of acetonitrile and 350 ml of methanol in 500 ml buffer as mobile phase at a flow rate of 2 ml/min and UV detection at 295 nm. Results:The sample found stable for 24 hrs in analyte solution and compatible with a nylon filter. The Beer's law plots were found to be linear over the concentration range 70-130% with a correlation coefficient (r 2 ) 0.9999 in diluent, phosphate buffer, and simulated tear media. The % relative standard deviation was found <2% shows good precision, acceptable accuracy, and reproducibility of the new method for the determination of besifloxacin hydrochloride. Conclusion:The method was validated as per the ICH guidelines. The method is accurate and can be applied for qualitative analysis of besifloxacin hydrochloride in bulk drug and in formulation.

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“…In a tear concentration PK study, topical administration of a single dose of besifloxacin 0.6% resulted in a maximum tear concentration in humans of 610 ± 540 µg/g, at 15 minutes post-instillation, with an average concentration of 1.6 µg/g or higher sustained for at least 24 hours. 17 …”

Section: Introductionmentioning

confidence: 99%

Concentrations of besifloxacin, gatifloxacin, and moxifloxacin in human conjunctiva after topical ocular administration

Torkildsen

Proksch²,

Shapiro³

et al. 2010

OPTH

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Purpose: To evaluate the pharmacokinetic properties of besifloxacin, gatifloxacin, and moxifloxacin in the conjunctival tissue of healthy volunteers after topical application. Methods: One-hundred eight (108) subjects were randomly assigned to receive one drop of besifloxacin (0.6% suspension), gatifloxacin (0.3% solution), or moxifloxacin (0.5% solution) ophthalmic formulations in one eye prior to conjunctival biopsy. Conjunctival samples were taken from subjects at either 15 minutes, 30 minutes, 2 hours, 6 hours, 12 hours, or 24 hours after dosing. Results: All three fluoroquinolones reached a peak mean concentration 15 minutes after dosing. The mean concentrations of besifloxacin, gatifloxacin, and moxifloxacin at 15 minutes were 2.30 ± 1.42 µg/g, 4.03 ± 3.84 µg/g, and 10.7 ± 5.89 µg/g, respectively. Concentrations decreased with each subsequent time point. At 24 hours after dosing, concentrations of besifloxacin were measurable in 4 of 6 subjects, compared with 3 of 6 subjects for gatifloxacin and 2 of 6 subjects for moxifloxacin. Besifloxacin had the greatest mean residence time (4.7 hours) in the conjunctival tissue. With regard to methicillin-resistant strains of Staphylococcus aureus and Staphylococcus epidermidis, besifloxacin had the greatest area-under-the-curve (AUC) to MIC 90 ratio. Nine percent (9%) of study subjects (N = 7) experienced a transient reduction in visual acuity. Conclusion: All three fluoroquinolones were well tolerated and reached levels in the conjunctiva above the MIC 90 s of methicillin-sensitive S. aureus and S. epidermidis for at least 2 hours.

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Quantitative determination of besifloxacin, a novel fluoroquinolone antimicrobial agent, in human tears by liquid chromatography–tandem mass spectrometry

Cited by 35 publications

References 15 publications

Ocular Pharmacokinetics of Besifloxacin Following Topical Administration to Rabbits, Monkeys, and Humans

Ocular Pharmacokinetics of Besifloxacin Following Topical Administration to Rabbits, Monkeys, and Humans

Uv-HPLC Method Development and Validation for Quantification of Besifloxacin Hydrochloride

Concentrations of besifloxacin, gatifloxacin, and moxifloxacin in human conjunctiva after topical ocular administration

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