Method for detecting dimethylamine in metformin hydrochloride

A technology of metformin hydrochloride and a detection method, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problems of no dimethylamine, large deviation of dimethylamine, etc., and achieve the effect of increasing sensitivity

Pending Publication Date: 2021-06-25
CHONGQING KERUI PHARMA GRP
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  • Description
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Problems solved by technology

[0004] Dimethylamine does not contain a chromophore, has no significant UV absorption, and cannot be directly detected by HPLC
[0007] After long-term testing and exploration, it was found that the detection methods provided by the 2018 edition of the British Pharmacopoeia and the 9.0 edition of the European Pharmacopoeia have the problem of large deviation of dimethylamine

Method used

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  • Method for detecting dimethylamine in metformin hydrochloride
  • Method for detecting dimethylamine in metformin hydrochloride
  • Method for detecting dimethylamine in metformin hydrochloride

Examples

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Embodiment 1

[0030] The present embodiment provides a kind of detection method of dimethylamine in metformin hydrochloride, specifically comprises the following steps:

[0031] S1. Prepare derivative solution, test solution, blank solution and reference solution;

[0032] (1) Derivative solution: take 1ml of 2,4-dinitrofluorobenzene in a 100ml volumetric flask, dissolve it with 40% acetonitrile aqueous solution to obtain a derivative solution;

[0033] (2) Test solution: Weigh 300mg of raw material drug in a 100ml volumetric flask, add 25ml of 40% acetonitrile aqueous solution, ultrasonicate for 5min, add 0.5ml of weak base reagent and 1ml of derivative solution, shake well, heat in a water bath at 50°C for 20min, after cooling Set the volume to the mark with a solvent, shake well to obtain the test solution with a concentration of 3 mg / ml;

[0034] (3) Blank solution: Measure 25ml of 40% acetonitrile aqueous solution, 0.5ml of weak base reagent, and 1ml of derivative solution in a 100ml ...

Embodiment 1-4

[0041]Embodiment 1-4 and comparative example

[0042] The comparative example is the detection of the content of dimethylamine in metformin hydrochloride in "European Pharmacopoeia" version 9.0.

[0043] The difference between embodiment 2 and embodiment 3 is only that the volume of derivative solution added in blank solution, need testing solution and reference substance solution is different.

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Abstract

The invention belongs to the technical field of pharmaceutical analysis, and particularly discloses a method for detecting dimethylamine in metformin hydrochloride, which comprises the following steps: S1, preparing a derivative solution, a test solution, a blank solution and a reference solution; and S2, determining the content of a derivatization product of dimethylamine. The detection method provided by the invention not only can more accurately determine the content of dimethylamine in metformin hydrochloride, but also can reduce the dosage of a derivative solution, reduce the detection cost and reduce pollution.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for detecting dimethylamine in metformin hydrochloride. Background technique [0002] With the development of society and economy, diabetes has become one of the diseases that seriously threaten the public health of the society. Metformin hydrochloride is a biguanide oral hypoglycemic agent with reliable curative effect and good safety. It has become the drug of choice for type 2 diabetes. Moderately reduce the weight of obese people, and have certain preventive and therapeutic effects on various gynecological diseases (such as polycystic ovary syndrome, endometrial cancer and ovarian cancer, etc.). [0003] Dimethylamine is a low-molecular-weight organic amine, which is the starting material in the synthesis of metformin hydrochloride. Close contact with it has a strong irritating effect on the eyes and respiratory tract. Eye contact with dimethylamine can cause ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8679
Inventor 蒋蒨李杰刘俊敏邹喜珍李春香吴华
Owner CHONGQING KERUI PHARMA GRP
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