RP-HPLC VALIDATION OF RELATED SUBSTANCES OF NEBIVOLOL IN BULK & 2.5/5/10/20 MG TABLETS
Journal Title: International Journal of Pharmaceutical, Biological and Chemical Sciences (IJPBCS) - Year 2012, Vol 1, Issue 2
Abstract
A gradient reverse phase HPLC method was developed for the determination of related substances in Nebivolol in bulk and their tablets. The known related substances are Desfuoroimpurity[1-(chroman-2-yl)-2-(2-(6fluorochroman-2-yl)-2-hydroxyethylamino)ethanol hydrochloride],Related compound-A [2S*{1R*,5R*(S*)}]-α,α`-[iminobis(methylene)]bis[6-fluoro-3,4-dihydro-2H-1-benzopyran-2-methanolhydrochloride] and benzylated impurity[2,2`-(Benzylazanediyl)bis(1-(6-fluorochroman-2yl)ethanol)oxalate]. The method was carried out on a Kinetex C18 column (75 x 4.6 mm; 2.6µ) using a mobile phase mixture of buffer pH 3.4, acetonitrile and water in a gradient elution at a flow rate of 1.0ml/min at wavelength of 280 nm. The impurities separated with a RRT of 0.9 for desfluoro, 1.06 for related impurity-A and 1.27 for benzylated impurity with respect to Nebivolol. The method can be used for the detection and quantitative estimation of known and unknown impurities in drug and pharmaceutical dosage form.
Authors and Affiliations
EDIGA SASI KIRAN GOUD*1 , V. KRISHNA REDDY2
Keywords
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- EP ID EP130252
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