A kind of detection method of mitiglinide calcium r-isomer

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...

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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

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