Shandilya Mahamuni Baira, S. R., M. K. Talluri
Feb 1, 2019
Citations
1
Influential Citations
6
Citations
Journal
Journal of Pharmaceutical and Biomedical Analysis
Abstract
Graphical abstract Figure. No Caption available. HighlightsStudy of stress degradation behaviour of alvimopan under stress conditions.A total of five degradation products (DP1‐DP5) were detected using HPLC.All the degradation products (DP1‐DP5) were identified by LC/MS/MS.Major degradation products (DP1‐DP3) were isolated by prep‐HPLC and subjected to NMR analysis. Abstract Alvimopan (ALV), a peripherally acting mu‐opioid receptor (PAM‐OR) antagonist used for the treatment of postoperative ileus, was examined for its degradation behaviour under different stress conditions. A total of five degradation products (DP1‐DP5) were formed and identified using high‐performance liquid chromatography (HPLC) method. Primarily, complete fragmentation pathways of the protonated drug and its degradation products (DP1‐DP5) were elucidated by using liquid chromatography‐mass spectrometry (LC/MS) and high‐resolution mass spectrometry (HRMS) studies. Subsequently, three major degradation products (DP1‐DP3) formed under acid hydrolytic stress conditions were isolated by preparative‐high performance liquid chromatography (prep‐HPLC) and subjected to nuclear magnetic resonance (NMR) experiments (1D and 2D NMR) for further confirmation of their structures. All the spectral data from LC/QTOF/MS/MS and NMR studies were used for the identification and structural characterization of degradation products (DP1‐DP5).