A Sensitive and Selective GC-MS Analysis of Process Related Genotoxic Impurities of Nebivolol Hydrochloride

摘要

A sensitive GC-MS method has been developed and validated for the estimation of genotoxic impurities namely 2-chloro-1-(6-fluorochroman 2-yl)ethanone (1), 2-chloro-1-(6-fluorochroman 2-yl)ethanol (2) and 6-fluoro2-(oxiran2-yl)chroman (3) in nebivolol hydrochloride dmg substance. Under optimized conditions of the proposed method is specific, precise, linear, accurate and rugged. The response was linear in the concentration range of limit of quantification to 0.07 mg g~(-1) with correlation coefficients of >0.99 for each impurity. Under optimum conditions used for the sample preparation the recovery of each impurity is in between 70-130 %.