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A kind of detection method of flumatinib mesylate related substance

A flumatinib mesylate and detection method technology, which is applied in the detection field of flumatinib mesylate related substances, can solve problems such as flumatinib mesylate not being recorded, and achieve strong specificity, The effect of accurate quantitative measurement results and improvement of drug safety

Active Publication Date: 2022-04-19
JIANGSU HANSOH PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, the quality standards of flumatinib mesylate are not recorded in the pharmacopoeias of various countries

Method used

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  • A kind of detection method of flumatinib mesylate related substance
  • A kind of detection method of flumatinib mesylate related substance
  • A kind of detection method of flumatinib mesylate related substance

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Embodiment Construction

[0034] It should be understood that those skilled in the art can make various modifications and improvements to the present invention based on the contents disclosed herein without departing from the spirit and scope of the present invention. They should all fall within the scope of patent protection defined by the claims of the present application. In addition, it should be understood that the examples provided herein are only for the purpose of illustrating the present invention and should not be construed as limitations of the present invention.

[0035] Impurities A and B are known impurities, and their preparation methods are described in CN201610595756.4 and CN201710621601.8.

[0036] Preparation of impurity C reference substance: Dissolve flumatinib mesylate (10.0g) in hydrogen peroxide (50mL, content 10%), stir at room temperature for 24h, add saturated aqueous sodium bicarbonate (100mL), and dissolve with ethyl acetate 100mL ×5 extracted, synthesized organic phase, d...

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Abstract

The invention provides an HPLC detection method for related substances of flumatinib mesylate. The detection condition of the method is a high-performance liquid chromatograph, including: gradient elution is carried out with a mobile phase after the substance to be detected is put on a chromatographic column, and the eluted product is detected, positioned and quantified. The method has strong specificity, high sensitivity, and accurate quantitative determination results, and can comprehensively detect flumatinib mesylate and its related substances, thereby improving drug safety.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for detecting related substances of flumatinib mesylate. Background technique [0002] The chemical name of flumatinib mesylate is 4-[(4-methyl-1-piperazinyl)methyl]-N-[6-methyl-5-[[4-(3-pyridyl)- 2-Pyrimidinyl]amino]pyridin-3-yl]-3-(trifluoromethyl)-benzamide methanesulfonate. [0003] [0004] In recent years, Gleevec, also known as imatinib, has become the first-line drug for the treatment of chronic myelogenous leukemia, but some patients develop drug resistance after using it. In most cases, resistance arises because BCR-ABL has mutated, resulting in a structural change in the enzyme that prevents Gleevec from binding to it. Flumatinib mesylate is a new generation of leukemia treatment drug developed by Jiangsu Hansoh Pharmaceutical Group Co., Ltd. on the basis of imatinib. It is mainly used for the treatment of chronic myeloid leukemia and can better sol...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 赵军军钟春华陈刚胜李倩
Owner JIANGSU HANSOH PHARMA CO LTD
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