On-line structure detection method for liquid phase components based on two-dimensional liquid chromatography and mass spectrometry

Abstract

The invention relates to an on-line structure detection method for liquid phase components based on two-dimensional liquid chromatography and mass spectrometry. The impurities in samples are detectedon line by high performance liquid chromatography and mass spectrometry, and the samples are selected from biological samples, drug samples, food samples and chemical samples. The on-line structure detection method comprises the following steps: (1) separating samples in a first-dimensional chromatograph, performing elution and desalination, and draining fractions cut from required fractions according to retention time into a quantitative ring mounted on a through valve, wherein the first-dimensional chromatograph contains a first mobile phase: (2) switching the through valve after drainage, and flushing the fractions onto a column head in a second-dimensional chromatograph through a second mobile phase in the second-dimensional chromatograph; (3) when the impurity content is lower and does not meet the detection sensitivity, repeating the steps (1) and (2) to accumulate the fractions on the column head, performing elution and desalination treatment, and flushing the treated fractionsinto a mass spectrometer for molecular weight or material structure debris detection.

Description

technical field [0001] The invention relates to an online structure detection method of liquid phase components based on two-dimensional liquid phase and mass spectrometry. Background technique [0002] Drugs (especially biological products such as proteins) or other chemical products such as food, pesticides, chemical raw materials, etc., will be modified or degraded in the process of production, transportation, storage, sales, and use. These modified degradation products (hereinafter referred to as impurities) may have an impact on product activity, side effects, and quality. Therefore, it is necessary to do sufficient research on the physical and chemical properties of impurities in the drug, in order to control their generation in the production process and prevent their generation during transportation and storage. This ensures that the quality of products such as pharmaceuticals can always meet quality standards from the factory to the patient or consumer. [0003] F...

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Problems solved by technology

[0011] The object of the present invention is to provide an online structure detection method of liquid phase components based on two-dimensional liquid phase and mass spectrometry, which solves the problem of analyzing various products (such as medicines, food, pesticides, and chemical products) of any high performance liquid chromatography. Difficulty in online molecular weight detection of impurities that can be separated by the method

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