We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Impurity Profiling of a Novel Anti-MRSA Antibacterial Drug: Alalevonadifloxacin.
- Authors
Patil, Kiran R; Rane, Vipul P; Ahirrao, Vinod K; Yeole, Ravindra D
- Abstract
Alalevonadifloxacin (ALA, formerly described as WCK 2349) is a novel antibacterial drug developed to treat infections caused by Gram-positive bacteria. The current study was aimed to identify and quantify impurities in ALA. Mass spectrometry (MS) compatible reverse phase liquid chromatographic method was developed to identify the impurities in ALA. Three impurities were identified based on the molecular ion peak and their product ions. These impurities were synthesized and characterized using MS and nuclear magnetic resonance spectrometry. However, this method was unable to resolve the diastereomeric impurity, which is likely to be formed during synthesis. Therefore, another method was developed using YMC Chiral NEA-[S] as a chiral stationary phase and validated for quantification of all impurities including diastereomeric impurity. The developed method was employed for quality control and stability studies of the ALA drug substance used in pre-clinical and clinical studies.
- Subjects
NATIONAL Education Association of the United States; CHIRAL stationary phases; DAUGHTER ions; NUCLEAR magnetic resonance; IONS; MASS spectrometry
- Publication
Journal of Chromatographic Science, 2020, Vol 58, Issue 10, p951
- ISSN
0021-9665
- Publication type
Article
- DOI
10.1093/chromsci/bmaa068