Isolation, Identification, and Characterization of Forced Degradation Products of Bosentan by Using Advanced Analytical Techniques

Abstract: The present study explains the degradation behavior of bosentan (BOS), active pharmaceutical ingredient (API) (BOS monohydrate), a Food and Drug Administration (FDA)–approved drug used for the treatment of chronic heart failure, subarachnoid hemorrhage, and Raynaud's syndrome pulmonary hypertension. The stress study was performed under various stress conditions such as acid hydrolysis, base hydrolysis, oxidation, thermal degradation, and photolysis as per International Council for Harmonization (ICH) guidelines and found three degradation products (DPs) under acid hydrolysis conditions (1 N HCl/4 h/60°C reflux conditions) (the net degradation of API ∼ 21.39%). The drug was found to be stable under the remaining conditions (thermal, photolytic, oxidative, and basic hydrolytic conditions). Mechanisms for forming the three acid DPs were also proposed and discussed. The DPs were initially detected by ultrahigh‐performance liquid chromatography–mass spectrometry analysis. These DPs were isolated by preparative HPLC and then characterized by high‐resolution mass spectrometry and nuclear magnetic resonance spectroscopy techniques. Based on the structural characterization study, all these DPs are new and not reported elsewhere in the literature to my knowledge. Many reports were found in the literature for the quantification of the drug in the APIs and formulation products. However, there is no report published yet for the identification and characterization of DPs of the BOS drug.

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• Standort: Deutsche Nationalbibliothek Frankfurt am Main
• Umfang: Online-Ressource
• Sprache: Englisch

Verweise und Beziehungen

• Erschienen in: Isolation, Identification, and Characterization of Forced Degradation Products of Bosentan by Using Advanced Analytical Techniques ; day:13 ; month:08 ; year:2024 ; extent:8 ; Separation science plus ; (13.08.2024) (gesamt 8)

Beteiligte, Orts- und Zeitangaben

• Urheber: Kanagaddi, Rajesh ; Nannapaneni, Satya Sree ; Raghupathi, Jayaprakash Kanijam ; Katari, Naresh Kumar ; Salakolusu, Suresh ; Murty, J. N. S. R. C. ; Ranga, Mahesh ; Kaliyaperumal, Muralidharan

Weitere Informationen

• DOI: 10.1002/sscp.202400194
• URN: urn:nbn:de:101:1-2408141429482.827344583411
• Rechteinformation: Open Access; Der Zugriff auf das Objekt ist unbeschränkt möglich.