A sensitive and selective GC-MS method for analysis of genotoxic impurities in dobutamine hydrochloride

Abstract

A sensitive GC-MS method for analysis of residues of Methyl-p-toluene sulfonate [Fig.2], Ethyl p-toluene sulfonate [Fig.3] and Isopropyl p-toluene sulfonate [Fig.4] Genotoxic impurities in Dobutamine hydrochloride [Fig.1] drug substance, has been developed and validated. Under the optimum conditions of the proposed method is specific, precise, linear, accurate and rugged. The response was linear in the concentration range of LOQ to 0.18 mg.g-1 with correlation coefficients of greater than 0.99 for each impurity. Under the optimum conditions used for the sample preparation the recovery of each impurity is in between 78-108%.