Abstract
In this paper the decomposition product of levofloxacin was identified. Levofloxacin was dissolved in 0.9% NaCl, 5% glucose, and Ringer’s solution. The solutions were divided into two batches: the first one was exposed to daylight and the second one was protected from it. The solutions were stored at the room temperature. The qualitative analysis of the degradation product was performed using MS and TOF detectors. The quantitative assay was done by a validated HPLC method. Visual inspection and pH assessment were done. Levofloxacin protected from daylight remained stable in 0.9% NaCl, 5% dextrose, and Ringer’s solution. A slight decomposition of the analyte was observed in the solutions exposed to daylight with the fastest decomposition rate in Ringer’s solution as compared with 0.9% NaCl and 5% dextrose solutions. The degradation product of levofloxacin detected with MS was levofloxacin N-oxide. Levofloxacin solutions should be protected from direct daylight to maintain drug stability. Levofloxacin N-oxide is formed regardless of the solvent used.
Highlights
Fluoroquinolones are group of the synthetic antibacterial drugs
This study presents the degradation product which might be formed during the use of the drug
We conducted the forced degradation of levofloxacin in a solar simulator to check if there were any differences in the formed decomposition products
Summary
Fluoroquinolones are group of the synthetic antibacterial drugs They have a broad spectrum of bactericidal activity against bacteria such as S. pneumoniae, P. aeruginosa, and B. fragilis. The matrices used in our study were the infusions (Ringer’s solution, 0.9% NaCl, and 5% dextrose) exposed and protected from daylight at the room temperature These solutions are the most common in clinical practice and might be considered as potential solvents for levofloxacin. We conducted the forced degradation of levofloxacin in a solar simulator to check if there were any differences in the formed decomposition products. Our manuscript comprises both the application study (in-use stability test) and the base study (the degradation in the solar simulator) concerning levofloxacin degradation in commonly used infusions
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