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Unique Quality by Design Approach for Developing HPLC and LC-MS Method for Estimation of Process and Degradation Impurities in Pibrentasvir, Antiviral Agent for Hepatitis C

[Image: see text] Pibrentasvir (PIB) was approved for treating hepatitis C patients. A specific, accurate, linear, robust, and stability-indicating method was developed and validated for determining degradation impurities present in the PIB drug substance by studying the quality by design (QbD) prin...

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Detalles Bibliográficos
Autores principales:	Vemuri, Divya Kumar, Akshinthala, Parameswari, Konduru, Naresh, Kowtharapu, Leela Prasad, Katari, Naresh Kumar, Jonnalagadda, Sreekantha Babu, Gundla, Rambabu
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	American Chemical Society 2022
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9798757/ https://www.ncbi.nlm.nih.gov/pubmed/36591161 http://dx.doi.org/10.1021/acsomega.2c04617

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