Authors
Sai Ram Prasad Kollu, Rayeesa Seema, Debasish Swain
Published in
Analytical methods : advancing methods and applications. Oct 16, 2026. Epub Oct 16, 2026.
Abstract
Tucatinib is a kinase inhibitor drug used to treat unresectable or metastatic HER-2 positive breast cancer in combination with Trastuzumab and Capecitabine. Forced degradation studies assess the inherent stability of pharmaceutical compounds, while LC-MS/MS facilitates the identification and characterization of the resulting degradation products. In the present study, the stability of Tucatinib (TCB) was investigated under various stress conditions (hydrolytic, photolytic, thermal, and oxidative conditions). It was demonstrated that TCB was susceptible to hydrolytic (acid, base, and neutral) as well as oxidative degradation, yielding 11 degradation products, of which 9 are reported for the first time. A validated UHPLC method was developed using an Agilent Eclipse Plus C18 (4.6 × 150 mm, 5 µm) column with gradient elution using 0.1% formic acid in water and methanol as mobile phases. Mass characterization of the degradation products was carried out on an Exploris 120 Orbitrap mass spectrometer using the same chromatographic conditions. Also, degradation kinetics was assessed to define the trend followed by TCB under different stress conditions. Thus, the present study effectively presents a detailed degradation profile of TCB, and the developed method finds its use for the routine analysis of TCB and formulation development in bulk and dosage forms.
PMID:
42885763
Bibliographic data and abstract were imported from PubMed on 16 Oct 2026.
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