Challenges with retention and recovery of impurities containing acidic moieties during analytical UHPLC method development and validation for gefapixant freebase

• Published in: Journal of pharmaceutical and biomedical analysis Vol. 237; p. 115772
• Main Authors: Halsey, Holst, Hall, Jackson, Huang, Chunli, Liu, Wenjun, Parganiha, Priya, Song, Siqing, Duran-Capece, Alicia, Fett, Joseph, Mathkar, Shilpa, Lohani, Sachin
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 05.01.2024
• Subjects: Acidic impurity; Charged surface hybrid; Gefapixant freebase; Peak shifting; UHPLC method; Acidic impurity; UHPLC method; Charged surface hybrid; Gefapixant freebase; Peak shifting

Gefapixant citrate is a P2X3 purinergic receptor antagonist developed for the treatment of chronic cough. Gefapixant freebase is the penultimate intermediate in the commercial manufacturing route for gefapixant citrate and contains a complex impurity profile consisting of acidic and basic analytes....