دورية أكاديمية
Identification and Characterization of Rotigotine Degradation Products by HPLC Coupled DAD and CAD Detectors and HRMS Through Q-Orbitrap and Electrospray Ionization.
| العنوان: | Identification and Characterization of Rotigotine Degradation Products by HPLC Coupled DAD and CAD Detectors and HRMS Through Q-Orbitrap and Electrospray Ionization. |
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| المؤلفون: | Mendes TC; Department of Drugs and Pharmaceutics, Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., Viana GM; Department of Drugs and Pharmaceutics, Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., de Abreu LCL; Instrumental Analysis Laboratory, Federal Institute of Rio de Janeiro, Rio de Janeiro, Brazil., Anselmo CS; Federal University of Rio de Janeiro, Institute of Chemistry, LBCD - LADETEC, Rio de Janeiro, Brazil., Pereira HMG; Federal University of Rio de Janeiro, Institute of Chemistry, LBCD - LADETEC, Rio de Janeiro, Brazil., da Silva AJR; Federal University of Rio de Janeiro, Natural Products Research Institute, Rio de Janeiro, Brazil., Cabral LM; Department of Drugs and Pharmaceutics, Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil., de Sousa VP; Department of Drugs and Pharmaceutics, Faculty of Pharmacy, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. Electronic address: valeria@pharma.ufrj.br. |
| المصدر: | Journal of pharmaceutical sciences [J Pharm Sci] 2024 May 29. Date of Electronic Publication: 2024 May 29. |
| Publication Model: | Ahead of Print |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6017 (Electronic) Linking ISSN: 00223549 NLM ISO Abbreviation: J Pharm Sci Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2016- : New York, NY : Elsevier Original Publication: Easton, Pa., American Pharmaceutical Assn. |
| مستخلص: | Rotigotine (RTG) is a dopamine agonist used in the treatment of Parkinson's disease. As it is susceptible to oxidation, stability studies must be carefully designed for the identification and characterization of all possible degradation products. Here, RTG degradation was evaluated according to the International Conference on Harmonization guidelines under various stress conditions, including acidic and basic hydrolysis, oxidative, metallic, photolytic, and thermal conditions. Additionally, more severe stress conditions were applied to induce RTG degradation. Significant degradation was only observed under oxidative and photolytic conditions. The samples were analyzed by high performance liquid chromatography coupled to photodiode array detectors, charged aerosol, and high-resolution mass spectrometry. Chromatographic analyses revealed the presence of eight substances related to RTG, four of which were already described and were qualified impurities (impurities B, C, K and E) and four new degradation products (DP-1 - DP-4), whose structures were characterized by high-resolution mass spectrometry through Q-Orbitrap and electrospray ionization. In the stress testing of the active pharmaceutical ingredient in solid form, significant RTG degradation was observed in the presence of the oxidative matrix. The results corroborate the literature that confirm the high susceptibility of RTG to oxidation and the importance of using different detectors to detect degradation products in forced degradation studies. 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. Published by Elsevier Inc.) |
| فهرسة مساهمة: | Keywords: Degradation product(s); HPLC (high-performance/pressure liquid chromatography); Liquid chromatography–mass spectrometry (LC–MS); Mass fragmentation; Oxidation(s); Photodegradation |
| تواريخ الأحداث: | Date Created: 20240530 Latest Revision: 20240621 |
| رمز التحديث: | 20240621 |
| DOI: | 10.1016/j.xphs.2024.05.028 |
| PMID: | 38815860 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1520-6017 |
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| DOI: | 10.1016/j.xphs.2024.05.028 |