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Method for detecting related substances of arbidol hydrochloride intermediate

A technology for arbidol hydrochloride and related substances, which is applied in the detection field of arbidol hydrochloride intermediates and related substances, achieving the effects of high repeatability, high sensitivity and good linear relationship

Active Publication Date: 2022-04-26
SHIJIAZHUANG NO 4 PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The by-products or unreacted raw materials introduced during the synthesis of Sr-5 may become impurities in the synthesis of Arbidol hydrochloride, and there is no relevant literature at present Therefore, it is urgent to develop a detection method that can effectively control the quality of Sr-5, and then ensure the effective control of the quality of Arbidol hydrochloride, so as to improve the industry standard

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  • Method for detecting related substances of arbidol hydrochloride intermediate
  • Method for detecting related substances of arbidol hydrochloride intermediate
  • Method for detecting related substances of arbidol hydrochloride intermediate

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Embodiments of the present invention provides a method of detecting the substance related to a abidorr hydrochloride intermediate, the detection method comprising the following steps:

[0049] Step 1: Prepare the test solution, control solution and blank solution;

[0050] Preparation of the control solution: ethyl 5-acetoxy-6-bromo-2-bromomethyl-1-methylindole-3-carboxylate, ethyl 1,2-dimethyl-6-bromo-5-hydroxyindole-3-carboxylate, 6,7-dibromo-5-hydroxy-1-methyl-2-benzothiol-3-carboxylate, 6-bromo-5-acetoxy-1-phenylthiomethyl-3-carboxylate, 6-bromo-5-acetoxy-1-methyl-2-benzenethiomethyl-3-carboxylate, 5- Hydroxy-1-methyl-2-phenylthiomethylindole-3-carboxylate ethyl ester and 6-bromo-5-hydroxy-1-methyl-2-phenylthiomethyl indole-3-carboxylate control, prepared with acetonitrile to make a control solution with a concentration of 3 μg / ml for each component;

[0051] Preparation of the test solution: take a sample of 6-bromo-5-hydroxy-1-methyl-2-benzothiol-3-carboxylate, and pr...

Embodiment 2

[0065] Embodiments of the present invention provides a method of detecting the substance related to a abidorr hydrochloride intermediate, the detection method comprising the following steps:

[0066] Step 1: Prepare the test solution and the control solution;

[0067] Preparation of the control solution: ethyl 5-acetoxy-6-bromo-2-bromomethyl-1-methylindole-3-carboxylate, ethyl 1,2-dimethyl-6-bromo-5-hydroxyindole-3-carboxylate, 6,7-dibromo-5-hydroxy-1-methyl-2-benzothiol-3-carboxylate, 6-bromo-5-acetoxy-1-phenylthiomethyl-3-carboxylate, 6-bromo-5-acetoxy-1-methyl-2-benzenethiomethyl-3-carboxylate, 5- Hydroxy-1-methyl-2-phenylthiomethylindole-3-carboxylate ethyl ester and 6-bromo-5-hydroxy-1-methyl-2-phenylthiomethyl indole-3-carboxylate control, prepared with acetonitrile to make a control solution with a concentration of 3 μg / ml for each component;

[0068] Preparation of the test solution: take a sample of 6-bromo-5-hydroxy-1-methyl-2-benzothiol-3-carboxylate and prepare a test ...

Embodiment 3

[0077] Embodiments of the present invention provides a method of detecting the substance related to a abidorr hydrochloride intermediate, the detection method comprising the following steps:

[0078] Step 1: Prepare the test solution and the control solution;

[0079] Preparation of the control solution: ethyl 5-acetoxy-6-bromo-2-bromomethyl-1-methylindole-3-carboxylate, ethyl 1,2-dimethyl-6-bromo-5-hydroxyindole-3-carboxylate, 6,7-dibromo-5-hydroxy-1-methyl-2-benzothiol-3-carboxylate, 6-bromo-5-acetoxy-1-phenylthiomethyl-3-carboxylate, 6-bromo-5-acetoxy-1-methyl-2-benzenethiomethyl-3-carboxylate, 5- Hydroxy-1-methyl-2-phenylthiomethylindole-3-carboxylate ethyl ester and 6-bromo-5-hydroxy-1-methyl-2-phenylthiomethyl indole-3-carboxylate control, prepared with acetonitrile to make a control solution with a concentration of 3 μg / ml for each component;

[0080] Preparation of the test solution: take a sample of 6-bromo-5-hydroxy-1-methyl-2-benzenethiomethyl indole-3-carboxylate, and ...

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Abstract

The invention relates to the technical field of pharmaceutical analysis, and particularly discloses a method for detecting related substances of an arbidol hydrochloride intermediate. The detection method comprises the following steps: preparing a test solution and a reference solution; the test solution and the reference solution are detected by liquid chromatography, and the chromatographic conditions of the liquid chromatography are as follows: a C18 chromatographic column is adopted, acetonitrile-water with the volume ratio of 63-67: 33-37 is taken as a mobile phase A, acetonitrile-methanol-water with the volume ratio of 38-42: 38-42: 18-22 is taken as a mobile phase B, and gradient elution is performed. According to the detection method provided by the invention, quantitative and qualitative analysis of the impurities INT1-B, INT1-C, INT1-D, INT1-E and INT1-F in the Sr-5 raw material medicine is realized, and the method is high in specificity and sensitivity and meets the detection requirements of the Sr-5 raw material medicine.

Description

Technical field [0001] The present invention relates to the field of pharmaceutical analysis techniques, in particular to a method of detecting a substance related to an Arbidol hydrochloride intermediate. Background [0002] Arbidol Hydrochloride is an immune-enhancing non-nucleoside broad-spectrum antiviral drug with chemical name 1-methyl-2-phenylthiomethyl-4-dimethylaminomethyl-5-hydroxy-6-bromo-1H-indole-3-carboxylate hydrochloride, which is used to treat upper respiratory tract infections caused by influenza A and B viruses. Arbidore, a non-nucleoside antiviral drug developed by the Soviet Research Center for Medicinal Chemistry, was first marketed in Russia in 1993 and has been used in Russia for many years to treat influenza. At present, the efficacy of Arbidol has been recognized and favored by international experts, and has been listed in Japan and some European countries, and was approved for listing in China in 2006. [0003] Sr-5 chemical name is 6-bromo-5-hydroxy-1...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8679
Inventor 张伟丽孙立杰石俭苏燕王静亚张漫段孟彤
Owner SHIJIAZHUANG NO 4 PHARMA