LC-MS/MS characterization of pirtobrutinib impurities and product degradation: stability studies.

Autor: Pavithra MK; Department of Chemistry, Bharathi College Bharathinagara Mandya 571 422 Karnataka India pavithramk664@gmail.com chayaguruswamy97@gmail.com., G C; Department of Chemistry, Bharathi College Bharathinagara Mandya 571 422 Karnataka India pavithramk664@gmail.com chayaguruswamy97@gmail.com., Deepakumari HN; Department of Chemistry, Bharathi College Bharathinagara Mandya 571 422 Karnataka India pavithramk664@gmail.com chayaguruswamy97@gmail.com.; Department of Chemistry, Regional Institute of Education (NCERT) Bhubaneswar 751022 Odisha India deepakumari_22@yahoo.com., Revanasiddappa HD; Department of Chemistry, University of Mysore Manasagangotri Mysuru 570 006 Karnataka India hdrevanasiddappa@yahoo.com., Mohammed SJ; Civil Engineering Department, Dijlah University College Baghdad 00964 Iraq salah.jasmin@duc.edu.iq., Majdi HS; Department of Chemical Engineering and Petroleum Industries, Al-Mustaqbal University College Babylon 51001 Iraq mn13022020@gmail.com., Alsabhan AH; Department of Civil Engineering, College of Engineering, King Saud University Riyadh 11421 Saudi Arabia aalsabhan@ksu.edu.sa., Ukkund SJ; Department of Biotechnology, P.A. College of Engineering Mangalore 574153 India drshareef2022@gmail.com.
Jazyk: angličtina
Zdroj: RSC advances [RSC Adv] 2024 Nov 01; Vol. 14 (47), pp. 34868-34882. Date of Electronic Publication: 2024 Nov 01 (Print Publication: 2024).
DOI: 10.1039/d4ra06299j
Abstrakt: This study examined the fragmentation, degradation pathways and DPs of pirtobrutinib, which have not been previously reported in the literature. The main goal of the current work is to develop, validate, and characterize forced degradation products using LC-MS/MS. An isocratic HPLC methodology was developed for the quantitative measurement of pirtobrutinib at a λ max of 219 nm. The procedure used was straightforward, well defined, proven, and selective. The samples were subjected to isocratic elution using an Agilent Eclipse C18 column (150 × 4.6 mm, 3.5 μ). The mobile phase was supplied at a flow rate of 1.0 mL per minute in a 30 : 70 v/v ratio, containing 0.1% formic acid and acetonitrile. A linear response was observed within the 0.0-150 μg mL -1 concentration range. It was found that the limits of quantitation and detection for pirtobrutinib were 0.1 and 0.3, respectively. The method was assessed for system suitability, linearity, precision, accuracy, and robustness in accordance with standard ICH guidelines. It was found that the results were within acceptable limits. A variety of stress conditions, such as acids, alkalis, hydrolysis, oxidation, reduction as well as photo- and thermal degradations, were applied to the drug to test the method's efficiency and stability. Acidic, alkaline, peroxide, and reduction conditions showed significant degradation. Degradation products produced during the forced degradation studies were analyzed and characterized using mass spectrometry (MS/MS). Thus, the proposed method can also be used for the quantitation of pirtobrutinib in the presence of its degradation products.
Competing Interests: The authors declare that they have no known personal relationships or competing financial interests that could have appeared to impact the work described in this paper.
(This journal is © The Royal Society of Chemistry.)
Databáze: MEDLINE
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