دورية أكاديمية
Identification of major degradation products of Clorsulon drug substance including its degradation pathways by high resolution mass spectrometry and NMR.
| العنوان: | Identification of major degradation products of Clorsulon drug substance including its degradation pathways by high resolution mass spectrometry and NMR. |
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| المؤلفون: | Zhao D; Global Pharmaceutical Technical Support (GPTS), Boehringer Ingelheim Animal Health USA Inc., North Brunswick, NJ 08902, USA. Electronic address: Daoli.Zhao@boehringer-ingelheim.com., Rustum AM; Global Pharmaceutical Technical Support (GPTS), Boehringer Ingelheim Animal Health USA Inc., North Brunswick, NJ 08902, USA. |
| المصدر: | Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2024 Aug 15; Vol. 246, pp. 116214. Date of Electronic Publication: 2024 May 10. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Science Country of Publication: England NLM ID: 8309336 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-264X (Electronic) Linking ISSN: 07317085 NLM ISO Abbreviation: J Pharm Biomed Anal Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2006->: London : Elsevier Science Original Publication: Oxford ; New York : Pergamon Press, c1983- |
| مواضيع طبية MeSH: | Magnetic Resonance Spectroscopy*/methods , Drug Stability* , Anthelmintics*/analysis , Anthelmintics*/chemistry, Chromatography, High Pressure Liquid/methods ; Mass Spectrometry/methods ; Oxidation-Reduction ; Photolysis |
| مستخلص: | Clorsulon is an effective anthelmintic drug substance extensively used in the treatment of parasitic infestations in both cattle and sheep. An in-depth investigation of Clorsulon's degradation products (DPs) was carried out through forced degradation study to comprehend its degradation path. A total of eight degradation products were separated under various stress degradation conditions. Structural elucidation of these DPs was conducted using ultra-high performance liquid chromatography-high resolution mass spectrometry (UHPLC-HRMS), and their fragmentation patterns were compared to that of the parent compound. Adequate amount of DP-4 was isolated and purified by semi-preparative high-performance liquid chromatography (HPLC) methods. Subsequently, it was examined in detail using both 1D and 2D NMR (nuclear magnetic resonance spectroscopy). Most probable mechanistic pathways for the formation of degradation products under various stress degradation conditions were proposed to better understand the degradation profile. Based on the results of the stress study, Clorsulon drug substance was found to be unstable under photolytic and oxidative conditions. Understanding Clorsulon's degradation pathway is essential for determining shelf-life prediction of the finished product, safety and efficacy assurance, and guiding the development of stable, high-quality formulations. Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper (Copyright © 2024 Elsevier B.V. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Clorsulon; Degradation Mechanism; Degradation Products; Forced Degradation Study; High Resolution Mass Spectrometry; Liquid Chromatography |
| المشرفين على المادة: | 0 (Anthelmintics) |
| تواريخ الأحداث: | Date Created: 20240523 Date Completed: 20240609 Latest Revision: 20240609 |
| رمز التحديث: | 20240610 |
| DOI: | 10.1016/j.jpba.2024.116214 |
| PMID: | 38781727 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1873-264X |
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| DOI: | 10.1016/j.jpba.2024.116214 |