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Determination of glycidol as a genotoxic impurity in linezolid drug substance by gas chromatography

Ravi kalgutkar, K.Ramakrishna, Shobha Shenoy, V.Srinivasarao

A gas chromatographic method has been developed for the determination of Glycidol in Linezolid drug substance. The method was optimized based on the basis of peak shape and response of Glycidol. 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/ml) and 10 ppm (10 µg/ml) respectively.