Impurity Profiling of a Novel Anti-MRSA Antibacterial Drug: Alalevonadifloxacin

Author:

Patil Kiran R1,Rane Vipul P1,Ahirrao Vinod K1,Yeole Ravindra D1

Affiliation:

1. Wockhardt Research Centre, D-4, MIDC, Chikalthana, Aurangabad 431006, India

Abstract

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.

Publisher

Oxford University Press (OUP)

Subject

General Medicine,Analytical Chemistry

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