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Investigation of nirmatrelvir epimerization occurred in analytical sample solution by using high resolution LC-MSn, NMR, and hydrogen/deuterium exchange study.
Zheng, Lewei; Wang, Lingqiao; Li, Dan; Xie, Chongjun; Gao, Zhiyuan; Lin, Jinsheng; Ye, Jian; Chen, Wenbin; Li, Min.
Afiliación
  • Zheng L; Center of Excellence for Modern Analytical Technologies (CEMAT) Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, PR China.
  • Wang L; Center of Excellence for Modern Analytical Technologies (CEMAT) Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, PR China.
  • Li D; Center of Excellence for Modern Analytical Technologies (CEMAT) Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, PR China.
  • Xie C; Center of Excellence for Modern Analytical Technologies (CEMAT) Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, PR China.
  • Gao Z; Center of Excellence for Modern Analytical Technologies (CEMAT) Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, PR China.
  • Lin J; Center of Excellence for Modern Analytical Technologies (CEMAT) Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, PR China.
  • Ye J; Center of Excellence for Modern Analytical Technologies (CEMAT) Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, PR China.
  • Chen W; Center of Excellence for Modern Analytical Technologies (CEMAT) Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, PR China.
  • Li M; Center of Excellence for Modern Analytical Technologies (CEMAT) Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, PR China; Huahai US, Inc. 700 Atrium Drive, Somerset, NJ 08873, USA. Electronic address: minli88@yahoo.com.
J Pharm Biomed Anal ; 227: 115284, 2023 Apr 01.
Article en En | MEDLINE | ID: mdl-36804289
During the related substances testing of nirmatrelvir, an unknown peak was observed and the level of the peak increased over time during the storage of the sample solution. By using a strategy including LC-PDA/UV-MSn analysis, the degradant was rapidly identified as an epimer of nirmatrelvir, a solution degradation product that is caused by the trace amount of alkaline impurities leaching from the glass HPLC vials. In addition, by using hydrogen/deuterium exchange NMR spectroscopy analysis, the epimerization position was determined to be the carbon α to the adjacent cyano group. Further investigation indicated that the occurrence of the solution degradation can be suppressed when the glass HPLC vials were replaced by plastic HPLC or mass spectrometric grade vials.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Espectrometría de Masas en Tándem / Hidrógeno Idioma: En Revista: J Pharm Biomed Anal Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Espectrometría de Masas en Tándem / Hidrógeno Idioma: En Revista: J Pharm Biomed Anal Año: 2023 Tipo del documento: Article Pais de publicación: Reino Unido