A novel liquid chromatography‐fluorescence method for the determination of delafloxacin in human plasma. Issue 3 (5th December 2021)

• Record Type: Journal Article
• Authors: Hernandis, Verónica; Escudero, Elisa; Marín, Pedro
• Is Part Of: Journal of separation science. Volume 45:Issue 3(2022)
• Page Start: 706
• Page End: 716
• Publication Date: 2021-12-05
• Subjects: delafloxacin -- fluorescence detection -- high‐performance liquid chromatography -- human plasma; Separation (Technology) -- Periodicals; Chromatographic analysis -- Periodicals; 543.089
• DOI: 10.1002/jssc.202100768
• Languages: English
• ISSNs: 1615-9306

Abstract

Abstract: Delafloxacin is a novel fluoroquinolone antibiotic that was approved by the European Medicine Agency to treat bacterial infections of the skin and underlying tissues, and community‐acquired pneumonia. Despite being in the market since 2019 in the European Union, there is no published liquid chromatography‐fluorescence method for delafloxacin quantification in biological samples. A novel, rapid, and sensitive high‐performance liquid chromatographic method was developed to determine delafloxacin in human plasma using its native fluorescence. Plasma delafloxacin concentrations were determined by reverse‐phase chromatography with fluorescence detection at 405/450 nm of excitation/emission wavelengths. Delafloxacin was separated on a Kromasil C18 column 250 × 4.6 mm id, 5 µm using isocratic elution. The mobile phase was a mixture of 0.05% trifluoroacetic acid/acetonitrile (52/48). Retention times were 5.4 and 11.6 min for delafloxacin and valsartan (internal standard), respectively. Regression calibration curves were linear over the range of 0.1–2.5 µg/mL. The lower limit of detection was 0.05 µg/mL, and the lower limit of quantification was 0.1 µg/mL. Accuracy and precision were always <11%, and the limit of quantification was <16%. Mean recovery was 98.3%. This method can be applied to determine delafloxacin in human plasma and could be useful to perform pharmacokinetic studies.