Method for detecting related substances of N-methyl-N '-tetrahydrofuranformyl propane diamine oxalate

A tetrahydrofuroylpropylenediamine oxalate and detection method technology, applied in the field of medicine, can solve the problems of large solvent interference, detection result influence, low response value of evaporative photodetector, etc., and achieve the effect of avoiding solvent interference

Active Publication Date: 2022-06-28
BANGENTAI (SHANDONG) BIOSCIENCES GRP SHARE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Therefore, the use of an evaporative light detector to check the related substances of this product was first considered. The results showed that the response value of the evaporative light detector was too low and the detection limit was too high to detect the impurities of this product.
Consider using gas chromatography for detection, the detection result is greatly affected by the vaporization temperature, and it is difficult to use gas chromatography detection method for effective detection
Therefore, an ultraviolet detector is selected to check the related substances of this product. Since this product is a small molecular compound, there is only terminal absorption (the maximum absorption is around 200nm), and there is a large solvent interference, which greatly affects the accuracy of detection.

Method used

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  • Method for detecting related substances of N-methyl-N '-tetrahydrofuranformyl propane diamine oxalate
  • Method for detecting related substances of N-methyl-N '-tetrahydrofuranformyl propane diamine oxalate
  • Method for detecting related substances of N-methyl-N '-tetrahydrofuranformyl propane diamine oxalate

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Embodiment

[0039] The synthesis process of N-methyl-N'-tetrahydrofuroyl propanediamine oxalate is accompanied by the occurrence of a side reaction to generate impurity AZ-MD-R-S3-IM03.

[0040] The detection method of N-methyl-N'-tetrahydrofuran formyl propanediamine oxalate related substances, the steps are as follows:

[0041] Step 1. Preparation of system suitability solution: the method is as follows: take about 10 mg of impurity AZ-MD-R-S3-IM03 reference substance, accurately weigh it, put it in a 20 mL volumetric flask, add diluent ultrasonically to dissolve it, and use diluent to dissolve it. Set the volume as the impurity stock solution; take about 50 mg of N-methyl-N'-tetrahydrofuroyl propanediamine oxalate reference substance, accurately weigh it, place it in a 10 mL volumetric flask, add a diluent to ultrasonically dissolve it, add Impurity stock solution 1mL, dilute to volume with diluent, shake well, as system suitability solution;

[0042] Step 2, preparation of the test s...

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Abstract

The invention discloses a method for detecting related substances of N-methyl-N '-tetrahydrofuranformyl propane diamine oxalate, liquid chromatography is adopted for detection, a chromatographic column is Waters XSelect HSS T3 with the size of 150mm * 4.6 mm and 3.5 mu m or YMC Triart C18 with the size of 150mm * 4.6 mm and 3.0 mu m, and a mobile phase A is a trifluoroacetic acid dilute solution; the mobile phase B is an acetonitrile solution containing trifluoroacetic acid. When the chromatographic column and the mobile phase are used for determination, a solvent peak, an impurity peak and a product main peak can be well separated, and when an ultraviolet detector is used for detection, solvent interference can be effectively avoided, so that the impurity content can be accurately detected.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a method for detecting a related substance of N-methyl-N'-tetrahydrofuroyl propanediamine oxalate. Background technique [0002] The statements herein merely provide background related to the present invention and do not necessarily constitute prior art. [0003] N-methyl-N'-tetrahydrofuroylpropanediamine is an important synthetic raw material, and the raw material is an oily substance, which contains a large amount of organic solvent, and has relatively poor stability, which is inconvenient for long-term storage. In general industrial production, it is basically used and prepared. Therefore, the inventors processed it into a salt, and the oxalate of this substance was proved to be industrially applicable. Since the purity directly affects the quality of the final product, the related substances need to be tested. [0004] The information of N-methyl-N'-tetrahydro...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/60G01N30/74
CPCG01N30/6052G01N30/74
Inventor 孙丽梦杨蓓蓓
Owner BANGENTAI (SHANDONG) BIOSCIENCES GRP SHARE CO LTD
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