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

Author:

Halsey HolstORCID,Hall Jackson,Huang ChunliORCID,Liu Wenjun,Parganiha Priya,Song Siqing,Duran-Capece Alicia,Fett Joseph,Mathkar Shilpa,Lohani SachinORCID

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference14 articles.

1. Development of a green and sustainable manufacturing process for gefapixant citrate (MK-7264) part 1: introduction and process overview;Ren;Org. Process Res. Dev.,2020

2. Development of a green and sustainable manufacturing process for gefapixant citrate (MK-7264). Part 5: completion of the API free base via a direct chlorosulfonylation process;Di Maso;Org. Process Res. Dev.,2020

3. Optimisation and characterisation of silica-based reversed-phase liquid chromatographic systems for the analysis of basic pharmaceuticals;Vervoort;J. Chromatogr. A,2000

4. The combined effect of silanols and the reversed-phase ligand on the retention of positively charged analytes;Neue;J. Chromatogr. A,2005

5. P.C. Iraneta, K.D. Wyndham, D.R. McCabe, T.H. Walter, Charged surface hybrid (CSH) technology and its use in liquid chromatography [White paper]. Retrieved July 6, 2022, from Waters Corp: https://www.waters.com/webassets/cms/library/docs/720003929en.pdf, (2011).

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