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Detection method of miglitol intermediate

A detection method, miglitol technology, applied in the detection field of miglitol intermediates, can solve the problem of inability to effectively detect residues and other unknown impurities, and inability to accurately control the intermediate N-hydroxyethylglucosamine Purity and other issues, to achieve the effect of convenient detection method, good durability, high separation

Pending Publication Date: 2021-07-09
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method cannot accurately control the purity of the intermediate N-hydroxyethylglucosamine, and cannot effectively detect the residual amount of glucose and ethylenediamine in the reaction starting materials and the content of other unknown impurities

Method used

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  • Detection method of miglitol intermediate
  • Detection method of miglitol intermediate
  • Detection method of miglitol intermediate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] (1) Sample preparation

[0061] Reference substance solution preparation: accurately weigh 100.02 mg of ethanolamine reference substance, place it in a 10ml measuring bottle, dissolve it with mobile phase and dilute to the mark, and use it as ethanolamine reference solution; precisely weigh 25.01 mg of glucose reference substance, place it in a 50ml measuring bottle , dissolved in mobile phase and diluted to the mark, as glucose control solution; accurately weighed 125.04 mg of Miglitol intermediate I reference substance, placed in a 25ml measuring bottle, dissolved in mobile phase and diluted to the mark, as Miglitol Alcohol intermediate I control solution.

[0062] Preparation of the test solution: Accurately weigh 125.02 mg of the crude product of Miglitol Intermediate I, place it in a 25ml measuring bottle, dissolve it with mobile phase and dilute to the mark, and use it as the test solution.

[0063] (2) Chromatography system detection

[0064] The reference subs...

Embodiment 2

[0073] (1) Sample preparation

[0074] Reference solution preparation: Accurately weigh 100.01mg of ethanolamine reference substance, place it in a 10ml measuring bottle, dissolve it with mobile phase and dilute to the mark, and use it as ethanolamine reference solution; accurately weigh 25.03mg of glucose reference substance, place it in a 50ml measuring bottle , dissolved in the mobile phase and diluted to the mark, as the glucose control solution; accurately weighed 125.01 mg of the reference substance of Miglitol intermediate I, placed in a 25ml measuring bottle, dissolved in the mobile phase and diluted to the mark, as the Miglitol Alcohol intermediate I control solution.

[0075] Preparation of the test solution: Accurately weigh 125.02 mg of the crude product of Miglitol Intermediate I, place it in a 25ml measuring bottle, dissolve it with mobile phase and dilute to the mark, and use it as the test solution.

[0076] (2) Chromatography system detection

[0077] The re...

Embodiment 3

[0086] (1) Sample preparation

[0087] Preparation of reference solution: accurately weigh 100.03mg of ethanolamine reference substance, place it in a 10ml measuring bottle, dissolve it with mobile phase and dilute to the mark, and use it as ethanolamine reference solution; precisely weigh 25.02mg of glucose reference substance, place it in a 50ml measuring bottle , dissolved in the mobile phase and diluted to the mark, as the glucose control solution; accurately weighed 125.01 mg of the reference substance of Miglitol intermediate I, placed in a 25ml measuring bottle, dissolved in the mobile phase and diluted to the mark, as the Miglitol Alcohol intermediate I control solution.

[0088] Preparation of the test solution: Accurately weigh 125.05 mg of the crude product of Miglitol Intermediate I, place it in a 25ml measuring bottle, dissolve it with mobile phase and dilute to the mark, and use it as the test solution.

[0089] (2) Chromatography system detection

[0090] The ...

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Abstract

The invention belongs to the technical field of pharmaceutical analysis, and particularly discloses a detection method of a miglitol intermediate . The method comprises the following steps: preparing a reference substance solution and a test sample solution, respectively injecting the reference substance solution and the test sample solution into a high performance liquid chromatograph, eluting by adopting an amino bonded phase chromatographic column and taking a methanol-acetonitrile-ammonium formate buffer solution system as a mobile phase, and detecting by using a differential refraction detector. The detection method can accurately detect the substrates glucose, ethanolamine and N-hydroxyethyl glucosamine at the same time, can completely separate the substrates glucose, ethanolamine and N-hydroxyethyl glucosamine from impurities, is high in separation degree, can accurately detect the purity of the target product N-hydroxyethyl glucosamine, and eliminate the influence of glucose, ethanolamine and impurities on N-hydroxyethyl glucosamine. The detection method disclosed by the invention is stable and reliable, and good in repeatability and durability, and a convenient detection method is provided for preparation and production of the miglitol intermediate.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a detection method of a miglitol intermediate. Background technique [0002] Diabetes is the most common disease caused by endocrine and metabolic disorders. It is mainly divided into type I diabetes and type II diabetes (non-insulin-dependent diabetes, NIDD), and type II diabetes is the main type. The current treatment methods for diabetes mainly include: diet therapy, exercise therapy, oral hypoglycemic drugs and subcutaneous injection of insulin. Commonly used drugs for the treatment of type II diabetes mainly include sulfonylureas, biguanides, and α-glucosidase inhibitors. Xanthonylureas mainly stimulate B cells to release insulin, but these drugs have relatively large side effects, such as hypoglycemia, gastrointestinal reactions, abdominal pain, liver damage, and severe weight gain. Biguanides mainly promote the uptake and utilization of glucose by muscl...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/047Y02P20/55
Inventor 张贵民刘志钰张波李旭娇
Owner LUNAN PHARMA GROUP CORPORATION
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