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Determination of benzyl bromide as a genotoxic impurity in donepezil hydrochloride using extraction technique by gas chromatography.

Ravikalgutkar1, B.Sandhyakumari, K.Ramakrishna, V.Srinivasarao

A gas chromatographic method has been developed for the determination of Benzyl bromide in Donepezil hydrochloride drug substance. Themethod was optimised based on the basis of solubility of Benzyl bromide. 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 6.6 ppm(6.6µg/mL) and 19.9 ppm (19.9 µg/mL) respectively.