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Method for detecting related substances of teriflunomide tablets

A technology of teriflunomide tablet and detection method, which is applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve the problem of no teriflunomide tablet, etc., and achieve the effects of overcoming difficulty in control, simple detection method and high accuracy.

Inactive Publication Date: 2021-02-02
CISEN PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is currently no effective method for the detection of related substances in teriflunomide tablets

Method used

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  • Method for detecting related substances of teriflunomide tablets
  • Method for detecting related substances of teriflunomide tablets
  • Method for detecting related substances of teriflunomide tablets

Examples

Experimental program
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Embodiment 1

[0023] 1. Instruments and utensils: high performance liquid chromatography (UV detector), electronic balance (one millionth, one hundred thousandth), volumetric flask (50mL, 100mL, 500mL), pipette (2mL), centrifuge.

[0024] 2. Reagents and reagents: Potassium dihydrogen phosphate (analytical grade), acetonitrile (chromatographic grade), ultrapure water, teriflunomide reference substance (USP), phosphoric acid.

[0025] 3. Preparation of test solution:

[0026] 3.1 Diluent: Potassium dihydrogen phosphate solution, adjust the pH to 3.2±0.5 with phosphoric acid.

[0027] 3.2 Reference substance solution: Accurately weigh 28mg of teriflunomide reference substance into a 500mL volumetric flask, add diluent to dissolve to volume; pipette 2mL into a 100mL volumetric flask, add diluent to dissolve to volume, and shake well.

[0028] 3.3 Sample solution: Accurately weigh 2 tablets of teriflunomide into a 50mL volumetric flask, add about 30mL of diluent to ultrasonically dissolve, pl...

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Abstract

The invention discloses a method for detecting related substances of teriflunomide tablets. According to the method, a gradient reverse liquid chromatography analysis method is adopted, and an ultraviolet detector is used for detecting related substances in the teriflunomide tablet, so the purpose of controlling the quality of the teriflunomide finished product is achieved. The detection method provided by the invention can simply, rapidly and accurately detect the content of known impurities and unknown impurities in the teriflunomide tablet, so that the disqualification risk and the production cost of a finished product are reduced, the quality of the product is ensured, and the detection method has a very good application and popularization value.

Description

technical field [0001] The invention belongs to the technical field of drug quality detection and control, in particular to a method for detecting related substances of teriflunomide tablets. Background technique [0002] Multiple sclerosis (MS) is an autoimmune disease characterized by inflammatory demyelinating lesions of the central nervous system; it is a chronic, disabling disease that may lead to paralysis, paralysis, and vision loss Loss; is the most common cause of disability in young people after trauma. [0003] Symptomatic treatments such as glucocorticoids and muscle relaxants are generally used clinically, but MS cannot be cured. In recent years, interferon-β and glatiramer acetate have been approved by the FDA as the first-line clinical treatment for MS. They need to be administered by injection, and the injection site is prone to redness and swelling , leading to poor patient compliance. On September 12, 2012, the FDA approved teriflunomide for the treatment...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/047
Inventor 郝延巍张玲孙久坤
Owner CISEN PHARMA
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