Characterization of two unknown impurities in roxithromycin by 2D LC–QTOF/MS/MS and NMR
2
Key Laboratory for Core Technology of Generic Drug Evaluation National Medical Product Administration, Zhejiang Institute for Food and Drug Control, Hangzhou, 310052, China.
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5
Zhejiang Guobang Pharmaceutical Co, Ltd., China
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Publication type: Journal Article
Publication date: 2020-05-01
scimago Q2
wos Q2
SJR: 0.628
CiteScore: 6.4
Impact factor: 3.1
ISSN: 07317085, 1873264X
PubMed ID:
32113121
Drug Discovery
Spectroscopy
Pharmaceutical Science
Clinical Biochemistry
Analytical Chemistry
Abstract
Two unknown impurities in roxithromycin were discovered and preliminarily characterized by two-dimensional liquid chromatography coupled with QTOF mass analyzer (2D LC-QTOF MS/MS). The column-switching technique of 2D LC made the chromatographic conditions in official standard of roxithromycin compatible with mass spectrometric detector. The complete MS/MS fragmentation patterns of the impurities were studied to obtain structural information of these impurities. Furthermore, these two impurities were separated and purified by preparative HPLC, and their structures were confirmed by 1D and 2D nuclear magnetic resonance (NMR). Structural elucidation of two impurities by 1H NMR, 13C NMR, the 1H-1H COSY, HSQC and HMBC NMR spectra has been discussed. Based on high resolution MS/MS and NMR data, the structures of these two impurities were elucidated respectively as 11-O-[(2-Methoxyethoxy) methyl] roxithromycin and de(N-methyl)-N-formyl roxithromycin. In addition, the mechanisms for formation of the impurities were also proposed.
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Total citations:
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Citations from 2024:
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Wang J. et al. Characterization of two unknown impurities in roxithromycin by 2D LC–QTOF/MS/MS and NMR // Journal of Pharmaceutical and Biomedical Analysis. 2020. Vol. 184. p. 113196.
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Wang J., Zhou J., Xu Yu., Zhu B., Jin Y. Characterization of two unknown impurities in roxithromycin by 2D LC–QTOF/MS/MS and NMR // Journal of Pharmaceutical and Biomedical Analysis. 2020. Vol. 184. p. 113196.
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TY - JOUR
DO - 10.1016/j.jpba.2020.113196
UR - https://doi.org/10.1016/j.jpba.2020.113196
TI - Characterization of two unknown impurities in roxithromycin by 2D LC–QTOF/MS/MS and NMR
T2 - Journal of Pharmaceutical and Biomedical Analysis
AU - Wang, Jian
AU - Zhou, Jinjin
AU - Xu, Yu
AU - Zhu, Bingqi
AU - Jin, Yong
PY - 2020
DA - 2020/05/01
PB - Elsevier
SP - 113196
VL - 184
PMID - 32113121
SN - 0731-7085
SN - 1873-264X
ER -
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@article{2020_Wang,
author = {Jian Wang and Jinjin Zhou and Yu Xu and Bingqi Zhu and Yong Jin},
title = {Characterization of two unknown impurities in roxithromycin by 2D LC–QTOF/MS/MS and NMR},
journal = {Journal of Pharmaceutical and Biomedical Analysis},
year = {2020},
volume = {184},
publisher = {Elsevier},
month = {may},
url = {https://doi.org/10.1016/j.jpba.2020.113196},
pages = {113196},
doi = {10.1016/j.jpba.2020.113196}
}