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

A technology of isomers and side chains, applied in the field of simultaneous detection of statin side chains and their isomer impurities, can solve the problems of low response and difficult detection, and achieve high sensitivity and accuracy

Active Publication Date: 2021-04-16
HEFEI COSOURCE PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

According to their structural formulas, these four materials are known to be alcohols. The response of the four isomers on the ultraviolet detector is very low and it is difficult to detect. Therefore, a method that can detect the statin side chain and its enantiomers is needed.

Method used

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

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Embodiment 1

[0025] Statin side chain I is commonly used as the starting material of rosuvastatin, pitavastatin, fluvastatin, etc. There are four isomers, the structure is as follows, Ia (starting material) and Ib are enantiomers of each other, Ic and Id are the epimers 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] A method for simultaneously detecting statin side chains and its isomer impurities, the steps comprising: injecting a system suitability solution and the test ...

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Abstract

The invention provides a method for simultaneously detecting statin side chain and its isomer impurities. The steps include: 1) taking the statin side chain and its isomers and adding it to a solvent to prepare a system suitability solution; 2) taking a sample of the statin side chain to be tested Add solvent to dilute the configuration test solution; 3) inject the system suitability solution and the test solution into the gas chromatograph, and record the spectrum; the sample to be tested is wherein R 1 for CH 2 OH, CHO, CN, CH 2 CH 2 NH 2 , CH 2 CH 2 One of Cl; R 2 for C 1 ‑C 4 one of the alkyl groups; R 3 for C 1 ‑C 4 one of the alkyl groups; R 4 for C 1 ‑C 4 one of the alkyl groups. The method for simultaneously detecting the statin side chain and its isomer impurities provided by the invention can effectively separate and detect the statin side chain and its isomer, and has high sensitivity, accuracy, accuracy and speed.

Description

technical field [0001] The invention relates to the field of chemical analysis, in particular to a method for simultaneously detecting statin side chains and isomer impurities. Background technique [0002] Statins are 3-hydroxy-3-methylglutaryl coenzyme A (HMGCoA) reductase inhibitors, which themselves or their metabolites are structurally similar to HMG-CoA, so they can competitively inhibit HMG in the early stages of cholesterol synthesis -CoA reductase activity, and 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, and the synthesis and release of very low-density lipoprotein are hindered due to the reduction of cholesterol synthesis by liver cells; at the same time, through its own regulatory mechanism, the compensatory increase of low-density lipoprotein on the...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 张蓉曹杰永汪吴林
Owner HEFEI COSOURCE PHARMA CO LTD
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