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

A technology for preparing liquid phase and chromatographic systems, applied in the field of separation and purification of target components, can solve problems such as failure to achieve separation effect and separation and purification.

Active Publication Date: 2021-08-06
PHARMARON BEIJING
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  • Abstract
  • Description
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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 sam

Method used

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

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Embodiment

[0109] A method for separating and purifying pharmaceutical impurities by using a two-dimensional high-pressure preparative liquid chromatography system, comprising the following steps:

[0110] S1. The one-dimensional separation column 13 is pre-balanced according to the pipeline connection in (I-I): wherein, the aqueous phase is ultrapure water (adding 0.05% trifluoroacetic acid, v / v), and the organic phase is acetonitrile; then through the software Set the ratio of the water phase to the organic phase, turn on the one-dimensional high-pressure chromatographic pump 11, so that the equilibrium liquid enters the first mixer 12, the one-dimensional separation column 13, and then enters the first detector 14 to carry out pre-balance (system pressure is stable, detection The baseline displayed by the instrument is stable), and the balance liquid finally enters the waste liquid receiving device 8.

[0111] According to the pipeline connection of (I-II), the first trapping column 6...

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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...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/14
CPCG01N30/06G01N30/14
Inventor 南海江刘志国周聪聪刘松岩钟明亮文大为杨定忠
Owner PHARMARON BEIJING
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