Method for detecting methanesulfonate genotoxic impurities in gemcitabine hydrochloride by GC-MS/MS method

Abstract

The invention relates to the technical field of drug analysis, and particularly relates to a method for detecting methanesulfonate genotoxic impurities in gemcitabine hydrochloride by a GC-MS/MS method. The method comprises the following steps of 1) adding 1, 2-dichloroethane into gemcitabine hydrochloride, performing ultrasonic treatment, adding 1, 2-dichloroethane to a constant volume to obtainan extracting solution, and filtering the extracting solution to obtain a test solution,2) determining the test solution in the step 1) by adopting a GC-MS/MS method, and calculating the content of each methanesulfonate genotoxic impurity in gemcitabine hydrochloride by adopting an external standard method, wherein the used gas chromatographic column is a VF-624ms chromatographic column, and the methanesulfonate genotoxic impurities comprise methyl methanesulfonate, ethyl methanesulfonate, isopropyl methanesulfonate, propyl methanesulfonate and butyl methanesulfonate. The determination methodprovided by the invention has the characteristics of strong impurity interference resistance, low noise, strong specificity and high sensitivity.

Description

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AI Technical Summary

Benefits of technology

This patented technology allows us to accurately determine how much certain chemical compounds have been found to cause harm or even death during medical treatments on cancer patients. By analyzing these samples from their sources, we aim to identify any potential health hazards associated therewith.

Problems solved by technology

This patent discusses the problem associated with identifying harmful compounds called metastable endocrins (METAs) during medicinal chemistry processes where they pose health concerns worldwide. Current methods involve analyzing large amounts of these potentially dangerous components through mass spectrometry techniques like liquidchromatography and gas chromatography. However, current analysis tools cannot accurately determine if certain compound(s) exist within limits set by international agreements stating safety standards proposed beforehand.

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