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A method for detecting the purity of osimertinib mesylate by liquid chromatography

A technology of osimertinib mesylate and liquid chromatography, which is applied in the field of material purity analysis, can solve the problems such as the purity detection method and unpublished detection method of osimertinib mesylate, which are not seen, and improve the separation effect. , reliable detection method, high repeatability effect

Active Publication Date: 2020-08-18
ENANTIOTECH CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, AstraZeneca has not disclosed its detection method, and there are no relevant literature and reports on the detection method of the purity of osimertinib mesylate. With the deepening of domestic research on this product, especially the improvement of the synthesis process, in order to To strengthen the quality control of osimertinib mesylate, there is an urgent need for sensitive and stable detection methods to monitor the quality of this product

Method used

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  • A method for detecting the purity of osimertinib mesylate by liquid chromatography
  • A method for detecting the purity of osimertinib mesylate by liquid chromatography
  • A method for detecting the purity of osimertinib mesylate by liquid chromatography

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Embodiment 1

[0029] A method for detecting the purity of osimertinib mesylate by liquid chromatography, comprising the following steps:

[0030] 1) Preparation of system adaptability solution: Take appropriate amount of osimertinib mesylate, 3-(2-chloropyrimidin-4-yl)-1-methylindole, N-(4-fluoro-2-methoxy Base-5-nitrophenyl)-4-(1-methyl-1H-indol-3-yl)-2-pyrimidinamine, N-(2-dimethylamino-ethyl)-2-methyl Oxy-n-methyl-n-[4-(1-methyl-1H-indol-3-yl)-pyrimidin-2-yl]-5-nitro-benzene-1,4-diamine, N1-[2-(Dimethylamino)ethyl]-5-methoxy-N1-methyl-N4-[4-(1-methyl-1H-indol-3-yl)-2-pyrimidine Base]-1,2,4-benzenetriamine was placed in the same volumetric flask, and a mixture of acetonitrile and water with a volume ratio of 1:1 was used to prepare a solution containing 1 mg of the above five substances per milliliter, and the system adaptation sex test solution;

[0031] 2) Preparation of the test solution: take an appropriate amount of the test product osimertinib mesylate, dissolve it in a mixture o...

Embodiment 2

[0048] A method for detecting the purity of osimertinib mesylate by liquid chromatography, comprising the following steps:

[0049]1) Preparation of system adaptability solution: Take appropriate amount of osimertinib mesylate, 3-(2-chloropyrimidin-4-yl)-1-methylindole, N-(4-fluoro-2-methoxy Base-5-nitrophenyl)-4-(1-methyl-1H-indol-3-yl)-2-pyrimidinamine, N-(2-dimethylamino-ethyl)-2-methyl Oxy-n-methyl-n-[4-(1-methyl-1H-indol-3-yl)-pyrimidin-2-yl]-5-nitro-benzene-1,4-diamine, N1-[2-(Dimethylamino)ethyl]-5-methoxy-N1-methyl-N4-[4-(1-methyl-1H-indol-3-yl)-2-pyrimidine Base]-1,2,4-benzenetriamine was placed in the same volumetric flask, and a mixture of acetonitrile and water with a volume ratio of 1:1 was used to prepare a solution containing 1 mg of the above five substances per milliliter, and the system adaptation sex test solution;

[0050] 2) Preparation of the test solution: take an appropriate amount of the test product osimertinib mesylate, dissolve it in a mixture of...

Embodiment 3

[0059] A method for detecting the purity of osimertinib mesylate by liquid chromatography, comprising the following steps:

[0060] 1) Preparation of system adaptability solution: Take appropriate amount of osimertinib mesylate, 3-(2-chloropyrimidin-4-yl)-1-methylindole, N-(4-fluoro-2-methoxy Base-5-nitrophenyl)-4-(1-methyl-1H-indol-3-yl)-2-pyrimidinamine, N-(2-dimethylamino-ethyl)-2-methyl Oxy-n-methyl-n-[4-(1-methyl-1H-indol-3-yl)-pyrimidin-2-yl]-5-nitro-benzene-1,4-diamine, N1-[2-(Dimethylamino)ethyl]-5-methoxy-N1-methyl-N4-[4-(1-methyl-1H-indol-3-yl)-2-pyrimidine Base]-1,2,4-benzenetriamine was placed in the same volumetric flask, and a mixture of acetonitrile and water with a volume ratio of 1:1 was used to prepare a solution containing 1 mg of the above five substances per milliliter, and the system adaptation sex test solution;

[0061] 2) Preparation of the test solution: take an appropriate amount of the test product osimertinib mesylate, dissolve it in a mixture o...

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Abstract

The invention discloses a method for detecting purity of osimertinib mesylate with a liquid chromatography. A Thermo fisher Hypersil GOLD Dim chromatographic column is adopted; the purity of a samplefor a test is calculated by an area normalization method; the test conditions of the liquid chromatography are set as follows: the column temperature of the chromatographic column is 25-35 DEG C; in gradient elution with two mobile phases, a mobile phase A is KH2PO4, a mobile phase B is acetonitrile, and the flow velocity of the mobile phases is 0.7-1.2mL / min; an ultraviolet detector is adopted, and the detection wavelength is 250-260nm. The detection method is simple, convenient, accurate, quick, reliable, highly repeatable and stable, and the osimertinib mesylate can be effectively separatedfrom known impurities, therefore, the simple, convenient, accurate, quick and reliable detection method is provided for industrial production of the osimertinib mesylate; the acetonitrile and monopotassium phosphate as the mobile phases are adopted for a certain proportion of gradient elution, so that the separation effect is improved; the pH value of the monopotassium phosphate is adjusted to 3.0, so that the peak patterns of a main peak and an impurity peak are improved.

Description

technical field [0001] The invention belongs to the technical field of substance purity analysis, relates to the detection method of the purity of osimertinib mesylate, known impurities and unknown impurities, and more specifically relates to the detection method of the purity of osimertinib mesylate by liquid chromatography, Methods for known impurities and unknown impurities. Background technique [0002] Osimertinib mesylate, whose CAS number is 1421372-66-8, is the third-generation oral epidermal growth factor receptor inhibitor developed by AstraZeneca. It is the first to be marketed in the world and the first to be approved in China. Oncology drugs for EGFR T790M mutation-positive locally advanced or metastatic non-small cell lung cancer. Osimertinib mesylate can effectively overcome the T790M resistance mutation caused by about 60% of Asian patients receiving the previous two generations of drug treatment, while reducing the risk of hyperglycemia, gastrointestinal an...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 蒙发明曹欢燕徐亮邓超芹樊志麒
Owner ENANTIOTECH CORP