Gradient RP-HPLC method for the determination of potential impurities in dabigatran etexilate in bulk drug and capsule formulations

A selective RP-HPLC method for separation and determination of potential related impurities (starting materials and by-products of synthesis, and degradants) of dabigatran etexilate (DAB) drug substance has been developed and validated. The separation was accomplished on a Inertsil ODS 3V (250 mm × ...

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Bibliographic Details
Main Authors: J. Nagadeep, P. Kamaraj, M. Arthanareeswari
Format: Article
Language:English
Published: Elsevier 2019-12-01
Series:Arabian Journal of Chemistry
Online Access:http://www.sciencedirect.com/science/article/pii/S1878535215002920