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ORIGINAL RESEARCH article

Front. Chem.
Sec. Analytical Chemistry
Volume 12 - 2024 | doi: 10.3389/fchem.2024.1450692

Development and validation of a novel high-performance liquid chromatography (HPLC) method for the detection of related substances of pralsetinib, a new antilung cancer drug

Provisionally accepted
Liangliang Cai Liangliang Cai 1*Yonghong Zhu Yonghong Zhu 2Jisu Qin Jisu Qin 1,2Wenyi Wu Wenyi Wu 3
  • 1 Nantong University, Nantong, China
  • 2 Affiliated Nantong Hospital of Shanghai University, Nantong, China
  • 3 Other, Nantong, China

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

    Background: Pralsetinib, a targeted inhibitor of the RET enzyme, plays a critical role in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by RET gene fusion mutations following platinum-based chemotherapy. Nevertheless, impurities resulting from the manufacturing and degradation of pralsetinib have the potential to impact its therapeutic effectiveness and safety profile.Methods: To address this issue, a liquid chromatography method was developed and validated for the specific identification of pralsetinib and its related impurities. The separation of pralsetinib and its related impurities was achieved via a Waters X Bridge C18 column with dimensions of 4.6 mm × 250 mm and a particle size of 5 μm. Mobile phase A was composed of 20 mmol/L potassium dihydrogen phosphate (KH2PO4) and acetonitrile (ACN) at a volume ratio of 19:1, while mobile phase B consisted solely of ACN, utilizing a gradient elution technique. Detection was performed at a wavelength of 260 nm, with an injection volume of 10 μL and a flow rate of 1.0 mL/min.The chromatographic method established in this study was validated according to the ICH Q2 (R1) guidelines. The method demonstrated excellent linearity over a specific concentration range (imp-A

    Keywords: Pralsetinib, Liquid Chromatography, method development, Method validation, Related substances

    Received: 18 Jun 2024; Accepted: 08 Aug 2024.

    Copyright: © 2024 Cai, Zhu, Qin and Wu. 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: Liangliang Cai, Nantong University, 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.