A method for simultaneous detection of statin side chain and its enantiomer impurities

A technology of enantiomers and side chains, applied in the field of chemical analysis, achieves the effect of simple method, improved resolution and short derivatization time

Active Publication Date: 2021-06-01
HEFEI COSOURCE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, there is no report on how to separate and detect the isomer configuration of the side chain

Method used

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  • A method for simultaneous detection of statin side chain and its enantiomer impurities
  • A method for simultaneous detection of statin side chain and its enantiomer impurities
  • A method for simultaneous detection of statin side chain and its enantiomer impurities

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Embodiment 1

[0025] Side chain I is commonly used as the side chain of rosuvastatin, pitavastatin, fluvastatin, etc. There are four isomers, the structure is as follows, Ia (side chain) and Ib are enantiomers of each other, Ic and Id It is the epimer of Ia, the configuration of Ia is the configuration required for the side chain in statin synthesis, and the other three are generally considered as impurities. The impurities in the side chain directly affect the impurities of the enantiomers and epimers of the final raw materials, and it is necessary to control them, first of all, a sensitive and accurate analysis method is required. According to its structural formula, it is an alcohol, and the response of the four isomers on the ultraviolet detector is very low, making it difficult to detect.

[0026]

[0027] It can be seen from the structural formula that the sample to be tested is a side chain alcohol, which has a very low response on the ultraviolet detector, and the response of the...

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Abstract

The invention discloses a method for simultaneously detecting statin side chains and their enantiomer impurities, and relates to the technical field of chemical analysis. The detection steps are as follows: derivatizing a sample to be tested with 3,5-dinitrobenzoyl chloride reaction, extract the reaction product, and then use normal phase high performance liquid chromatography to separate and detect with ultraviolet light. The present invention is based on the low response of the statin side chain on the ultraviolet detector, and adopts 3,5-dinitrobenzoyl chloride for the derivatization reaction, the derivatization time is short, the responsivity of the sample can be increased, and the separation degree of the sample can be improved, thereby The method effectively separates and detects the statin side chain and its enantiomer, has high sensitivity, accuracy and speed, and the method is simple, and can be widely used in the detection and control of the enantiomer of the statin side chain in the statin side chain.

Description

technical field [0001] The invention relates to the technical field of chemical analysis, in particular to a method for simultaneously detecting statin side chains and their enantiomer impurities. Background technique [0002] Statins are 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors, which themselves or metabolites are structurally similar to HMG-CoA, so they can competitively inhibit the early stages of cholesterol synthesis The activity of HMG-CoA reductase (the affinity of statins to this enzyme is 10,000 times stronger than that of HMG-CoA), thereby reducing the synthesis of endogenous cholesterol and reducing the level of total cholesterol in plasma. The liver is the main site of endogenous cholesterol synthesis[7] (accounting for about 70% of the total), and the synthesis and release of very low-density lipoprotein are hindered due to the reduction of cholesterol synthesis in liver cells; at the same time, through its own regulatory mechanism, t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/74
CPCG01N30/02G01N30/06G01N30/74G01N2030/027G01N2030/067
Inventor 孙宏张程开生苏俊
Owner HEFEI COSOURCE PHARMA CO LTD
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