A Mass Spectrometric Detection Method of Sulfonate Genotoxic Impurities Based on Dielectric Barrier Discharge Ion Source

Abstract

The invention provides a mass spectrometry detection method of sulfonate genotoxic impurities based on a dielectric barrier discharge ion source, and belongs to the technical field of pharmaceutical analysis. The method comprises the following steps: a sample solution is dripped as a sample point at a certain interval in the length direction of the sample table, the sample point is dried naturally, the dielectric barrier discharge ion source is aligned with the mass spectrometer at the front end of the sample point, the dielectric barrier discharge ion source is turned on, the heating platformand the mass spectrometer are in a working state, and mass spectrometry analysis and detection are carried out. A method for directly detect genotoxic impurities in medicine by dielectric barrier discharge ionization mass spectrometry is disclosed, From the sample preparation to the result, the rapid detection and analysis of the genotoxic impurity methyl p-toluenesulfonate in the drug can be completed in a few minutes. The established method can detect and analyze the methyl p-toluenesulfonate in the drug sensitively and quickly, thus realizing the high-throughput drug screening, and has good practical application value.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a rapid mass spectrometric detection method for sulfonate genotoxic impurities based on a dielectric barrier discharge ion source. Background technique [0002] Genotoxic impurities refer to substances that can directly or indirectly damage DNA, cause gene mutation or have a tendency to cause cancer. Genotoxic impurities mainly come from the starting materials, intermediates, reagents and reaction by-products during the synthesis of APIs. In addition, drugs may also be degraded to produce genotoxic impurities during synthesis, storage, or formulation. Genotoxic impurities are characterized by causing damage to human genetic material at very low concentrations, and are mutagenic and carcinogenic, and seriously threaten human health in the course of medication. In recent years, with the increasing regulatory requirements for genotoxic impurities, regulatory agen...

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Problems solved by technology

In 2007, it was found in the detection of the HIV drug nelfinavir (Viracept) that the level of ethyl methanesulfonate exceeded the standard due to the reaction of methanesulfonic acid in the raw material with residual ethanol, which led to the withdrawal of the product from the European market

At present, there is no report on the accurate and sensitive analysis of sulfonate genotoxic impurities using dielectric barrier discharge ion source

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