Two-dimensional high-pressure preparative liquid chromatography system and separation and purification method for low-content target components in medicine

Abstract

The invention relates to the technical field of preparative liquid chromatography separation, and particularly discloses a two-dimensional high-pressure preparative liquid chromatography system and a separation and purification method for low-content target components in a medicine. The system comprises a first-dimensional high-pressure preparative liquid chromatography system, a two-position six-way switching valve, a multi-position selection valve, a trapping column and a second-dimensional high-pressure preparative liquid chromatography system, the second-dimensional high-pressure preparative liquid chromatography system comprises a second mixer and a two-dimensional separation column; the first-dimensional high-pressure preparative liquid chromatography system is sequentially communicated with the two-position six-way switching valve, the multi-position selection valve and the trapping column, and the outlet end of the trapping column is communicated with the two-position six-way switching valve again; and the second mixer is sequentially communicated with the two-position six-way switching valve and the two-dimensional separation column. The method comprises the following steps: detecting a sample by using a one-dimensional system, and trapping a target component to a trapping column; and switching the two-position six-way switching valve, back-washing out captured components, and carrying out two-dimensional detection. The method disclosed by the invention has the advantage of efficiently separating and purifying impurity components with extremely low content in the medicine.

Description

technical field [0001] The application relates to the technical field of medical technology and preparative liquid chromatography separation, more specifically, it relates to a two-dimensional high-pressure preparative liquid chromatography system and a method for separation and purification of low-content target components in medicines. Background technique [0002] Any substance that affects the purity of a drug is collectively referred to as an impurity. The study of impurities is an important part of drug research and development, closely related to drug production, safety and efficacy, and is one of the key quality attributes of drugs. The United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) clearly stipulate that the structure of impurities with an apparent content of ≥0.1% must be confirmed before clinical use of the drug, and impurities with strong biological effects and toxicity with an apparent content of less than 0.1% Impurities and degradation p...

AI Technical Summary

Problems solved by technology

However, the first-dimensional separation system uses a low-pressure or medium-pressure preparative liquid chromatography system to achieve the resolution of complex samples, which cannot achieve the separation effect, and ultimately cannot achieve effective separation and purification of low-content target components in complex samples.

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