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ORIGINAL RESEARCH article

Front. Chem.
Sec. Analytical Chemistry
Volume 12 - 2024 | doi: 10.3389/fchem.2024.1534132
This article is part of the Research Topic Recent Advances in Pharmaceutical Analysis: Applications and New Challenges for the Quality of Medicines View all 6 articles

Research on detection methods of related substances and degradation products of the antitumor drug selpercatinib

Provisionally accepted
Jingjing Xiang Jingjing Xiang 1Liangliang Cai Liangliang Cai 2Qin Wang Qin Wang 2Yonghong Zhu Yonghong Zhu 1*Yong Han Yong Han 3
  • 1 Sixth People's Hospital of Nantong, Nantong, China
  • 2 Affiliated Hospital of Nantong University, Nantong, Jiangsu Province, China
  • 3 Shanghai General Hospital, Shanghai, China

The final, formatted version of the article will be published soon.

    Background: Selpercatinib, a selective RET kinase inhibitor, is approved for treating various cancers with RET gene mutations such as RET-rearranged thyroid cancer and non-small cell lung cancer. The presence of process-related and degradation impurities in its active pharmaceutical ingredient (API) can significantly affect its safety and effectiveness. However, research on detecting these impurities is limited.Methods: This study developed and systematically validated a High-Performance Liquid Chromatography (HPLC) method for identifying selpercatinib and its related impurities. The method utilized a 4.6 mm × 250 mm chromatographic column with 5 μm particles, employing a flow rate of 1.0 mL/min, a detection wavelength of 235 nm, an injection volume of 10 μL, and a column temperature of 35 °C. Mobile phase A was composed of a 9:1 ratio of water to acetonitrile, with the aqueous component adjusted to pH 2.5 and containing 2 mM potassium dihydrogen phosphate (KH2PO4) and 0.4% triethylamine. Mobile phase B was pure acetonitrile. The gradient elution

    Keywords: Selpercatinib, Related substances, Degradation products, method development, method validation; Liquid Chromatography

    Received: 25 Nov 2024; Accepted: 27 Dec 2024.

    Copyright: © 2024 Xiang, Cai, Wang, Zhu and Han. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Yonghong Zhu, Sixth People's Hospital of Nantong, Nantong, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.