The Department of Physical Pharmacy and Pharmacokinetics, Poznań University of Medical Sciences, Święcickiego 6 Street, 60-781, Poznań, Poland.
The Department of Forensic Medicine, Poznań University of Medical Sciences, Święcickiego 6 Street, 60-781, Poznań, Poland.
Sci Rep. 2019 Mar 6;9(1):3621. doi: 10.1038/s41598-019-40201-9.
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.
本文鉴定了左氧氟沙星的分解产物。左氧氟沙星分别溶解于 0.9%氯化钠、5%葡萄糖和林格氏溶液中。将溶液分为两批：第一批暴露于日光下，第二批避光保存。溶液在室温下储存。使用 MS 和 TOF 检测器进行降解产物的定性分析。通过验证的 HPLC 方法进行定量分析。进行目视检查和 pH 值评估。避光保存的左氧氟沙星在 0.9%氯化钠、5%葡萄糖和林格氏溶液中保持稳定。在暴露于日光下的溶液中观察到分析物略有分解，其中在林格氏溶液中的分解速度最快，与 0.9%氯化钠和 5%葡萄糖溶液相比。用 MS 检测到的左氧氟沙星的降解产物为左氧氟沙星 N-氧化物。为了保持药物稳定性，左氧氟沙星溶液应避光保存。无论使用哪种溶剂，都会形成左氧氟沙星 N-氧化物。
