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Isolation, identification and characterization of potential impurities of anidulafungin

descriptionPublicationkeyboard_double_arrow_right Article 01 Jul 2017 English Publisher:Elsevier BVJournal:Journal of Pharmaceutical and Biomedical Analysis, volume 141, pages 192-199 (issn: 0731-7085,

Authors: Lanning Zhao; Qilong Wang; Yi Bie; Xiaoxia Lu;

doi: 10.1016/j.jpba.2017.04.014

pmid: 28448888

Isolation, identification and characterization of potential impurities of anidulafungin

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Abstract

Eight impurities ranging from 0.03 to 0.97% in anidulafungin bulk drug were detected by HPLC. Four impurities (Imp-I, Imp-II, Imp-III and Imp-VIII) among impurities were isolated from the self-prepared or marketed samples of anidulafungin bulk drug by means of preparative HPLC. A thorough study was undertaken to characterize these impurities and based on 1D (1H, 13C, H-D, DEPT 90 and 135) and 2D (COSY, TOCSY, HSQC, HMBC) NMR and ESI-MS spectral data. Based on the characterization data, Imp-I was found to be known open-chain hydrolysis product formed during the synthesis and degradation. Imp-II and Imp-III was lacked a methyl group at the C-4 and C-8 in anidulafungin, respectively, whereas Imp-VIII contained a methoxy group at the C-23. The latter three new impurities were identified as process-related substances.

Related Organizations

Chinese Academy of Sciences
China (People's Republic of)
Chengdu Institute of Biology
China (People's Republic of)

Keywords

Echinocandins, Magnetic Resonance Spectroscopy, Anidulafungin, Drug Contamination, Chromatography, High Pressure Liquid

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