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A kind of detection method of mitiglinide calcium r-isomer

A technology of mitiglinide calcium and isomers, which is applied in the field of identification of mitiglinide calcium R-isomers, can solve the problem that the separation degree cannot meet the legal requirements

Active Publication Date: 2022-05-31
JIANGXI JINSHUIBAO PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Among them, the R-isomer test method can separate the mitiglinide calcium peak from the R-isomer peak, but the resolution cannot meet the statutory requirements

Method used

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  • A kind of detection method of mitiglinide calcium r-isomer
  • A kind of detection method of mitiglinide calcium r-isomer
  • A kind of detection method of mitiglinide calcium r-isomer

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example 1

[0076] Detection wavelength: 210 nm.

[0078] Column temperature: 30 °C

example 2

[0088] Detection wavelength: 210 nm.

[0090] Column temperature: 30 °C

example 3

[0100] Detection wavelength: 210 nm.

[0102] Column temperature: 30°C

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Abstract

The present invention relates to a kind of detection method of mitiglinide calcium R-isomer, adopts high performance liquid chromatography, described method comprises the following steps: 1) preparation of need testing solution: get mitiglinide calcium crude drug Need testing sample appropriate amount, accurately weighed, add mobile phase and make every 1ml contain the solution of 0.2mg, shake up and get final product; 2) preparation of mitiglinide calcium reference substance solution: take mitiglinide calcium reference substance in right amount, Accurately weighed, add mobile phase to make a solution containing 0.2mg per 1ml, shake well; 3) preparation of mitiglinide calcium R-isomer reference solution: take mitiglinide calcium R-isomer Appropriate amount of body reference substance, accurately weighed, add mobile phase to make a solution containing 0.2mg per 1ml, and shake well; A high-performance liquid chromatograph obtains a chromatogram, and calculates the content of the R-isomer of mitiglinide calcium in the mitiglinide calcium bulk drug according to the normalization method according to the peak area in the chromatogram.

Description

A kind of detection method of mitiglinide calcium R-isomer technical field The present invention relates to a kind of identification method of mitiglinide calcium R-isomer. Background technique Mitiglinide calcium dihydrate, chemical name is: two [(2s)-2-benzyl-3-(cis-hexahydroisoindole-2-carbonyl) Propionic acid] monocalcium dihydrate, the structural formula is as follows: [0003] Mitiglinide calcium is the hypoglycemic drug developed by Japanese orange raw company, is a kind of novel benzyl succinic acid class insulin secretion. accelerator. Mitiglinide causes Ca2+ influx by closing the ATP-dependent K+ channel on the pancreatic β-cell membrane, making the intracellular Increased Ca2+ concentration degranulates extracellular insulin-containing vesicles, thereby stimulating insulin secretion. Mitiglinide Calcium Tablets Postprandial blood glucose control in patients with type 2 diabetes who cannot achieve satisfactory results with diet and exercise therapy. Mi...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/047
Inventor 陈小敏李义保马利雄张克勤彭常春易耀江
Owner JIANGXI JINSHUIBAO PHARM CO LTD
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