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Detection method of topiroxostat tablets

A technique for a topiramast tablet and a detection method, which is applied in the field of drug analysis, can solve the problems of low accuracy and repeatability, few detection methods for topiralast, etc., and achieves strong specificity, good linear relationship, high accuracy and high accuracy. good precision

Inactive Publication Date: 2020-09-25
CP PHARMA QINGDAO CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In the existing detection technology of topirast tablets, there are few detection methods for topirast, and there are generally problems of low accuracy and repeatability

Method used

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  • Detection method of topiroxostat tablets
  • Detection method of topiroxostat tablets
  • Detection method of topiroxostat tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment 1 needs testing solution preparation

[0027] Take an appropriate amount of fine powder of this product, add methanol to dissolve and dilute to make a sample solution containing about 5 μg of topirast in every 1 ml, filter, and take the subsequent filtrate as the test solution.

Embodiment 2

[0028] Example 2 Preparation of reference substance solution

[0029] Take an appropriate amount of topirax reference substance and add methanol to make a solution containing 5 μg of topiramate per 1 ml as the reference substance solution.

Embodiment 3

[0030] Example 3 Establishment of detection method

[0031] (1) Linear range

[0032] Take an appropriate amount of the reference substance of this product, dissolve it with a diluent and quantitatively dilute it to make a solution containing about 0.5 mg of topirast in every 1 ml, as the stock solution of the test product. Precisely measure 1ml of the stock solution of the test product, put it in a 10ml measuring bottle, add methanol to dilute to the mark, shake well, and use it as the test solution for each concentration gradient. Accurately measure 10 μl of each test solution, inject it into the liquid chromatograph, and record the chromatogram. Perform linear regression on the peak area A from the concentration C of the test solution, and the test results are shown in Table 1.

[0033] Table 1 Results of linearity test of topirast

[0034]

[0035] The results showed that: within the concentration range of 9.65-77.19 μg / ml of topirast, the peak area had a good linear...

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PUM

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Abstract

The invention relates to a detection method of topiroxostat tablets, and belongs to the field of pharmaceutical analysis. According to the detection method of topiroxostat tablets, topiroxostat is detected through an HPLC method. According to the detection method disclosed by the invention, the topiroxostat is good in linear relationship, good in accuracy and precision, strong in specificity and high in stability. The detection method is good in reproducibility, can meet the detection requirements of topiroxostat bulk drugs, and can be used for quality control of topiroxostat tablets.

Description

technical field [0001] The invention relates to the field of drug analysis, in particular to a detection method for topiralast tablets. The detection method has good reproducibility, can meet the detection requirements of topirast in topirast tablets, and can be used for quality control of topirast tablets. Background technique [0002] Topirast, the chemical name is 4-[5-(pyridin-4-yl)-1H-1,2,4-triazol-3-yl]pyridine-2-carbonitrile, and its structural formula is: [0003] [0004] Molecular formula: C13H8N6 [0005] Molecular weight: 248.24 [0006] Hyperuricemia refers to the serum uric acid value exceeding 7.0mg / dL, which is the main cause of urate deposition (gouty arthritis, kidney injury, etc.), and the serum uric acid concentration exceeds the solubility in body fluids. Gout is when the blood uric acid level rises, microscopic crystals of sodium urate in a supersaturated state precipitate out and deposit in tissues or organs such as joints, synovium, tendon, kidn...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 孙桂玉袁航陈安珍陈阳生刘晓霞臧云龙王明刚杜昌余张怀征朱锐马庆童
Owner CP PHARMA QINGDAO CO LTD
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