Method for detecting genotoxic impurities in lidocaine hydrochloride

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...

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Hauptverfasser: JIANG YUNYUN, XUE TONGXUAN, WANG YAJING, GAO MINGWEI, LIU YUQING, LI XIAOMEI, FAN SIYU, FAN YANLONG
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Sprache:chi ; eng
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INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES
MEASURING
PHYSICS
TESTING
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creator JIANG YUNYUN
XUE TONGXUAN
WANG YAJING
GAO MINGWEI
LIU YUQING
LI XIAOMEI
FAN SIYU
FAN YANLONG
description 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
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subjects INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES
MEASURING
PHYSICS
TESTING
title Method for detecting genotoxic impurities in lidocaine hydrochloride
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