Method for detecting genotoxic impurities in lidocaine hydrochloride

The invention relates to the technical field of pharmaceutical analysis, and particularly discloses a method for detecting genotoxic impurities in lidocaine hydrochloride. According to the method disclosed by the invention, 2, 2-dichloro-N-(2, 6-dimethyl phenyl) acetamide in lidocaine hydrochloride is detected by adopting a high performance liquid chromatography and mass spectrometry combined method. The detection conditions are as follows: a C18 chromatographic column; a mobile phase A is an aqueous solution of formic acid with the volume concentration of 0.05%-0.15%, and a mobile phase B is a methanol solution of formic acid with the volume concentration of 0.05%-0.15%; eluting in a gradient elution mode; mass spectrum conditions are as follows: an ESI ion source and a negative ion scanning mode. The detection method provided by the invention is strong in specificity, high in sensitivity and good in linear relationship, can be used as a basis for monitoring the quality of lidocaine hydrochloride, makes up t