ISOLATION AND STRUCTURAL ELUCIDATION OF IMPURITY IN NEBIVOLOL
AbstractIn the synthesis of Nebivolol [a mixture of (1RS, 1′ RS)-1,1′-{(2RS, 2′ SR)-bis(6-fluoro 3, 4-dihydro-2H-1-benzopyran-2-yl)} -2,2′-iminodiethanol] having four chiral centers, one crucial isomeric impurity at 0.88 RRT was observed in HPLC related substance analysis in gradient HPLC method. This impurity was isolated from synthesized crude impurity substance by preparative HPLC with chiral normal phase and was elucidated as [(R)-1-[ (R)-6-Fluorochroman -2-yl]-2-({(R)-2- [(R)-6-Fluorochro man-2-yl] -2-hydroxyethyl} amino) ethanol] (R, R, R, R- Nebivolol) by means of chromatographic and spectral data. Structural elucidation carried out by spectral data was reviewed.
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