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Determination of 1,2-dibromoethane as a genotoxic impurity in escitalopramoxalate drug substance by gas chromatography

Ravi kalgutkar,V.Srinivasarao,K.Ramakrishna

A simple gas chromatographic method has been developed for the determination of 1,2-Dibromoethane in Escitalopram oxalate drug substance. The method was validated as per ICH guideline in terms of LOD, LOQ, Method precision, accuracy and specificity. The LOD and LOQ values were found to be 3 ppm (3 µg/g) and 10 ppm (10 µg/g) respectively.