1Indoco Remedies Ltd., TTC Industrial Area, Rabale, Navi Mumbai - 400701, Maharashtra
2Department of Chemistry, Maharashtra Udaygiri College, Udgir - 413517, Maharashtra
3Research Center in Chemistry, K. J. Somaiya College, Kopargaon - 423601, Maharashtra
The four impurities in Brimonidine Tartrate bulk drug substances were detected by newly developed gradient reverse phase high performance liquid chromatography (HPLC) method. These impurities were named as Brimonidine Impurity- A, B, C, and D. The Brimonidine Impurity-A, Brimonidine Impurity-B, Brimonidine Impurity-C were process impurities, while Brimonidine Impurity-D is degradation impurity. The degradation Brimonidine Impurity-D was isolated by semi preparative HPLC. Structural elucidation of unknown impurities was carried out by means of (conformed by) spectral studies like IR, NMR and Mass synthesized authentic compounds.
Brimonidine Tartrate, Impurities, Isolation, Characterization
