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Method for detecting content of new drug topiroxostat tablet for treating gout

A technique of topinostat and a detection method, which is applied in the field of medicine, can solve problems such as obvious side effects, and achieve the effects of improving reproducibility, good control, and reliable test results

Inactive Publication Date: 2021-02-23
CP PHARMA QINGDAO CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the number of gout patients in my country is still increasing, and there is a trend of spreading to a younger age. Therefore, anti-gout drugs have great potential in the Chinese market. However, most of the anti-gout drugs on the market are old drugs. Although they are cheap, they have obvious side effects. , if there are new drugs launched in time, the market prospect will be very impressive

Method used

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  • Method for detecting content of new drug topiroxostat tablet for treating gout
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  • Method for detecting content of new drug topiroxostat tablet for treating gout

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Example 1. Linear test

[0015] Chromatographic conditions:

[0016] Chromatographic column: Merck C18 (150×4.6mm×5μm)

[0017] Methanol: 20mmol / L potassium dihydrogen phosphate (adjust pH to 3.2 with phosphoric acid)-acetonitrile (80:20)

[0018] Detection wavelength: 220nm; flow rate: 1.0ml / min; injection volume: 10μl

[0019] 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 topirastat per 1 ml, as the test sample stock solution. Precisely measure 1ml of the test sample stock solution, put it in a 10ml volumetric flask, add methanol to dilute to the mark, shake well, and use it as the test solution for each concentration gradient. Precisely measure 10 μl of each test solution, inject it into a liquid chromatograph, and record the chromatogram. A linear regression was performed on the peak area A by the concentration C of the test solution, a...

Embodiment 2

[0024] Example 2. Injection precision

[0025] Prepare the test solution with a concentration of 0.05mg / ml, inject 6 times continuously, record the chromatogram, and investigate the injection precision. The results are shown in Table 2:

[0026] Table 2 Injection precision test results

[0027]

[0028] The test results show that this method has good injection precision and is suitable for content determination.

Embodiment 3

[0029] Example 3. Sample solution stability

[0030] Take this product, dissolve it with methanol and dilute it into a test solution with a concentration of about 50μg / ml, inject the sample at 0, 2, 4, 6, and 8 hours respectively, record the peak area and calculate the average value and relative standard deviation. The results are shown in table 3:

[0031] Table 3 Sample solution stability

[0032]

[0033] The results showed that the test solution for the content determination of this product was stable within 8 hours.

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Abstract

The invention discloses a method for detecting the content of a new drug topiroxostat tablet for treating gout, which uses high performance liquid chromatography to determine the content of the new drug topiroxostat tablet, can improve the reproducibility, and enables the detection result to be more reliable, and thereby the product quality of the new drug topiroxostat tablet is better controlled.

Description

technical field [0001] The invention relates to a method for detecting a drug, in particular to a method for detecting the content of topirastat tablets, a new drug for treating gout, and belongs to the technical field of medicine. Background technique [0002] Uric acid is a normal product of purine nucleotide metabolism. When the production of uric acid is excessive and the excretion of uric acid is reduced, the increase of uric acid in the blood exceeds the normal range to form hyperuricemia; the excessive uric acid in the blood is mainly deposited in the joints, cartilage, Subcutaneous soft tissue and kidneys cause comprehensive clinical manifestations such as arthritis and renal disease, which is called gout. Therefore, hyperuricemia and uric acid deposition in organs and tissues are the basic pathogenesis of gout. The etiology of elevated uric acid is more complex and can be divided into two categories: primary and secondary. With the improvement of people's living st...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74
CPCG01N30/06G01N30/74
Inventor 刘晓霞陈阳生孙桂玉臧云龙王明刚刘振玉刘薇薛文静王婷婷
Owner CP PHARMA QINGDAO CO LTD
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