Isolation, identification, characterization, synthesis and quality control strategy of new process-related impurities in ambrisentan.

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2019
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Abstract
Ambrisentan is a highly selective endothelin-A receptor antagonist for the treatment of pulmonary arterial hypertension (PAH). The analysis of the process-related impurities will help not only to optimize the process parameters but also to develop reasonable analytical methods and set the quality standard for a quality control strategy in pharmaceutical manufacturing. During the manufacture of ambrisentan, five unknown impurities were detected in pilot batches ranging from 0.05% to 0.15% by HPLC. All of these impurities were isolated and synthesized successfully and were identified and characterized by LC-MS, HRMS, ESI-MS/MS(Q-Tof), 1D-NMR (H, C, DEPT) and 2D-NMR (COSY, HSQC, HMBC) techniques. The formation mechanisms that yield these impurities are discussed for the first time. Quality control strategies to deal with these impurities are developed to obtain bulk drug of ICH-grade quality.
Reference Key
feng2019isolationjournal Use this key to autocite in the manuscript while using SciMatic Manuscript Manager or Thesis Manager
Authors Feng, Wei-Dong;Zhuo, Song-Ming;Zhang, Fu-Li;
Journal Journal of pharmaceutical and biomedical analysis
Year 2019
DOI
S0731-7085(18)31987-3
URL
Keywords
impurity quality control 2d-nmr ambrisentan ms/ms

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