The degradation of levofloxacin in infusions exposed to daylight with an identification of a degradation product with HPLC-MS

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.

Analytical methods for the determination of certain antibiotics used in critically ill patients

“…Levofloxacin degradation products were identified in this study using HPLC-MS and TOF detectors while the quantitative assay was done by a validated HPLC method using isocratic elution with a mobile phase composed of acetonitrile and 0.4% triethylamine solution adjusted to pH 2.5 with orthophosphoric acid (24:76, v/v) at a flow rate 1 ml/min on a column (250 × 4 mm, 5 µm) with guard column (4 × 4 mm, 5 µm) and with UV detection at 295 nm [42] .…”

Response Surface Methodology as a Useful Tool for Evaluation of the Recovery of the Fluoroquinolones from Plasma—The Study on Applicability of Box-Behnken Design, Central Composite Design and Doehlert Design

“…Fluoroquinolones are the antibacterial agents that possess a wide bactericidal activity against Gram-positive (for example S. Pneumoniae) and Gram-negative (for example P. aeruginosa or B. Fragilis) bacteria [1,2]. They can be found in different matrices such as pharmaceutical formulations, biological samples (blood, serum, saliva) or food samples (meat).…”

Development and Validation of Stability-Indicating HPLC Methods for the Estimation of Lomefloxacin and Balofloxacin Oxidation Process under ACVA, H2O2, or KMnO4 Treatment. Kinetic Evaluation and Identification of Degradation Products by Mass Spectrometry

“…One of the specific, most promising, and intensely studied drug groups in modern antibiotic therapy, which well-known from the susceptibility for the degradation process are fluoroquinolones (FQs) [ 20 , 21 , 22 ]. This group occupy a very important place in modern medicine due to the broad spectrum of antibacterial activity, the possibility of oral and parenteral administration, good absorption, achieving high therapeutic concentrations in tissues and body fluids, rapid elimination from the body, chemical, and biological stability [ 23 ].…”