Characterization of 28 unknown impurities in 16-membered macrolides by liquid chromatography coupled with ion trap/time-of-flight mass spectrometry.

Autor: Liu G; Zhejiang University of Technology, Hangzhou 310014, China., Zhu B; Zhejiang Chinese Medical University, Hangzhou 310053, China., Ren X; Zhejiang University of Technology, Hangzhou 310014, China., Wang J; Zhejiang University of Technology, Hangzhou 310014, China; Key Laboratory for Core Technology of Generic Drug Evaluation National Medical Product Administration, Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China. Electronic address: wangjianhw2000@aliyun.com.
Jazyk: angličtina
Zdroj: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2020 Jul 15; Vol. 186, pp. 113324. Date of Electronic Publication: 2020 Apr 22.
DOI: 10.1016/j.jpba.2020.113324
Abstrakt: In terms of risk assessment, the study of the impurity profile is important to ensure the safety and effectiveness of drugs in clinical application. Sixteen-membered macrolides are produced by microbial fermentation, and many closely related substances in the product make the components and impurities complicated. In this study, methods were developed to separate and identify the impurities in three representative 16-membered macrolides (josamycin, midecamycin and meleumycin) using a high-performance liquid chromatography coupled to high-resolution ion trap/time-of-flight mass spectrometry (IT-TOF MS). In total, 53 impurities were characterized in the positive mode of electrospray ionization, among which 28 novel impurities were found. The proposed structures of impurities were deduced based on MS/MS data, and the ultraviolet (UV) absorption behaviors of impurities were discussed. In addition to the impurities with maximum absorption wavelengths (λ max ) of 231 nm and 280 nm, there was a new group of impurities with λ max of 205 nm in meleumycin, midecamycin and josamycin.
Competing Interests: Declaration of Competing Interest The authors declare that they have no conflict of interests.
(Copyright © 2020 Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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