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Method for determining related substances of 6-acetoxy-7-methoxy-3H-quinazoline-4-ketone

A technology of acetoxy and related substances, applied in the field of drug analysis and detection, can solve problems such as low sensitivity, poor detection quality, and complicated operation

Inactive Publication Date: 2021-04-30
南京百泽医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, after the drug is produced, it is necessary to detect the substance of 6-acetoxy-7-methoxy-3H-quinazolin-4-one to confirm that 6-acetoxy-7-methoxy - the effects and characteristics of 3H-quinazolin-4-one drugs, yet, when the existing detection method detects 6-acetoxy-7-methoxyl-3H-quinazolin-4-one drugs, its Impurities are similar in structure and difficult to separate, and cannot quickly detect the content of each impurity in 6-acetoxy-7-methoxy-3H-quinazolin-4-one. The operation is complicated and the sensitivity is low, so it cannot be detected well Mass in 6-acetoxy-7-methoxy-3H-quinazolin-4-one

Method used

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  • Method for determining related substances of 6-acetoxy-7-methoxy-3H-quinazoline-4-ketone
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  • Method for determining related substances of 6-acetoxy-7-methoxy-3H-quinazoline-4-ketone

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Embodiment Construction

[0037] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention more clear, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments It is a part of embodiments of the present invention, but not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

[0038] structure:

[0039] 6-Acetoxy-7-methoxy-3H-quinazolin-4-one

[0040]

[0041] BZP00231:

[0042]

[0043] BZP00240:

[0044]

[0045] BZP00241:

[0046]

[0047] The invention provides a method for determining related substances of 6-acetoxy-7-methoxy-3H-quinazolin-4-one, such as Figure 1-3 As shown, usi...

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Abstract

The invention discloses a method for determining related substances of 6-acetoxy-7-methoxy-3H-quinazoline-4-ketone. The metohd adopts fluorophenyl silane bonded silica gel as a filler and a potassium dihydrogen phosphate buffer acetonitrile mixed solution as a mobile phase, gradient elution is carried out, and a sample solvent is an acetonitrile aqueous solution. The detection method is accurate, simple and convenient to operate, good in reproducibility, good in sensitivity and specificity, capable of meeting detection of related substances of an antitumor drug gefitinib starting material 6-acetoxyl-7-methoxy-3H-quinazoline-4-ketone, capable of well controlling special impurities in a sample, capable of ensuring the product quality and high in practicability in work.

Description

technical field [0001] The invention belongs to the technical field of drug analysis and detection, and in particular relates to a method for determining related substances of 6-acetoxy-7-methoxy-3H-quinazolin-4-one. Background technique [0002] 6-Acetoxy-7-methoxy-3H-quinazolin-4-one is an important starting material of gefitinib, so its related substances need to be controlled to ensure the quality of the finished product. Gefitinib is mainly aimed at patients with advanced lung adenocarcinoma with epidermal growth factor receptor positive. pathway, can play an inhibitory role, and is mainly suitable for the first-line treatment of patients with advanced lung adenocarcinoma epidermal growth factor receptor positive. [0003] At present, after the drug is produced, it is necessary to detect the substance of 6-acetoxy-7-methoxy-3H-quinazolin-4-one to confirm that 6-acetoxy-7-methoxy - the effects and characteristics of 3H-quinazolin-4-one drugs, yet, when the existing det...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 陈文芝李静崔雍堃
Owner 南京百泽医药科技有限公司
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