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Malic acid isomer detection method

A detection method and malic acid technology, applied in the field of medicine, can solve problems such as interference in detection of L-malic acid isomers, and achieve the effects of satisfying accuracy, convenient detection and avoiding interference.

Pending Publication Date: 2021-03-09
SICHUAN TAIPINGYANG PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] At present, there is no report on the detection method of L-malic acid isomers in compound electrolyte injection in domestic and foreign literatures. The inorganic salt and water contained in compound electrolyte injection will interfere with the detection of L-malic acid isomers, so it is necessary to Establish a new detection method to effectively detect the content of L-malic acid isomers in compound electrolyte injection. Therefore, a detection method for malic acid isomers is proposed

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  • Malic acid isomer detection method

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Embodiment 1

[0032] see figure 1 , the present invention provides a kind of technical scheme: the detection method of malic acid isomer, comprises the following steps:

[0033] S1. Provide a standard addition mixed solution: take 1 weight part of L-malic acid, 1 weight part of D-malic acid, 1.5 weight parts of maleic acid and 3 weight parts of fumaric acid reference substance, dissolve and quantitatively dilute with mobile phase to prepare Each 1ml contains about 1mg of L-malic acid, 10μg of D-malic acid, 5μg / ml of fumaric acid and 5μg / ml of maleic acid into the volumetric flask, shake well to obtain a mixed solution;

[0034] S2. Chromatographic detection of the mixed solution: gradient detection of the mixed solution by liquid chromatography, the retention times of L-malic acid and D-malic acid in the chromatogram of the mixed solution are 11.1 min respectively, and the degree of separation is 2.5;

[0035] S3. Improve separation detection: improve the separation between maleic acid pea...

Embodiment 2

[0053] see figure 1 , the present invention provides a kind of technical scheme: the detection method of malic acid isomer, comprises the following steps:

[0054] S1. Provide a mixed solution for adding standard: take 2 parts by weight of L-malic acid, 1.5 parts by weight of D-malic acid, 1.7 parts by weight of maleic acid and 3.2 parts by weight of fumaric acid reference substance, dissolve and quantitatively dilute with mobile phase to prepare Add a mixed solution containing 1.5mg of L-malic acid, 11μg of D-malic acid, 6μg / ml of fumaric acid and maleic acid in each 1.3ml into the volumetric flask, shake well to obtain a mixed solution;

[0055] S2. Chromatographic detection of the mixed solution: gradient detection of the mixed solution by liquid chromatography, the retention times of L-malic acid and D-malic acid in the chromatogram of the mixed solution are 12 minutes respectively, and the degree of separation is 2.5;

[0056] S3. Improve separation detection: improve th...

Embodiment 3

[0074] see figure 1 , the present invention provides a kind of technical scheme: the detection method of malic acid isomer, comprises the following steps:

[0075] S1. Provide a standard addition mixed solution: take 3 parts by weight of L-malic acid, 2 parts by weight of D-malic acid, 2 parts by weight of maleic acid and 3.5 parts by weight of a fumaric acid reference substance, dissolve and quantitatively dilute with mobile phase to prepare Add a mixed solution containing about 2mg of L-malic acid, 13μg of D-malic acid, 7μg / ml of fumaric acid and maleic acid in each 1.5ml into the volumetric flask, shake well to obtain a mixed solution;

[0076] S2. Chromatographic detection of the mixed solution: gradient detection of the mixed solution by liquid chromatography, the retention times of L-malic acid and D-malic acid in the chromatogram of the mixed solution are 12.1 min respectively, and the degree of separation is 3;

[0077] S3. Improve separation detection: improve the se...

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Abstract

The invention discloses a malic acid isomer detection method which comprises the following steps: S1, providing a standard adding mixed solution, taking 1-3 parts by weight of L-malic acid, 1-2 partsby weight of D-malic acid, 1.5-2 parts by weight of maleic acid and 3-3.5 parts by weight of a fumaric acid reference substance, dissolving by using a mobile phase and quantitatively diluting to prepare a mixed solution containing about 1-2mg of L-malic acid, 10-13mu g of D-malic acid, 5-7mu g of fumaric acid and 5-7mu g of maleic acid in each 1-1.5 ml of the mixed solution, and adding the mixed solution into a volumetric flask; S2, performing chromatographic detection of the mixed solution: performing gradient detection on the mixed solution through liquid chromatography, wherein the retention time of L-malic acid and the retention time of D-malic acid in the chromatogram of the mixed solution are 11.1-12.1 min respectively, and the separation degree is 2.5-3. According to the method, themixed solution is detected through chromatographic detection of the mixed solution so that primary contrast of the malic acid isomer is obtained, secondary mixed detection is conducted on the malic acid isomer through chromatographic detection of the mixed solution, detection for improving the separation condition and other methods, the detection result is more accurate, and detection of workersis facilitated.

Description

Technical field: [0001] The invention relates to the technical field of medicine, in particular to a detection method for malic acid isomers. Background technique: [0002] Compound Electrolyte Injection can be used as a supplementary source of water and electrolytes and an alkalinizing agent. It is compatible with blood and blood components. It can be infused before or after blood transfusion with the same drug delivery device, that is, it can be used as a priming solution. In transfused blood components, or as a diluent for blood cells. [0003] At present, there is no report on the detection method of L-malic acid isomers in compound electrolyte injection in domestic and foreign literatures. The inorganic salt and water contained in compound electrolyte injection will interfere with the detection of L-malic acid isomers, so it is necessary to To establish a new detection method to effectively detect the content of L-malic acid isomers in compound electrolyte injection. T...

Claims

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Application Information

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IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8877
Inventor 李勇王利华文娟
Owner SICHUAN TAIPINGYANG PHARMA