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Method for determining related substances of new drug topiroxostat tablet

A technology of topicastat and related substances, applied in the field of medicine, can solve the problems of obvious side effects and the like

Inactive Publication Date: 2021-03-12
CP PHARMA QINGDAO CO LTD +1
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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 determining related substances of new drug topiroxostat tablet
  • Method for determining related substances of new drug topiroxostat tablet
  • Method for determining related substances of new drug topiroxostat tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014]Example 1 Input-to-spectrum conditions

[0015]Columns: C18 (Merck C18, 150 × 4.6mm, 5 μm);

[0016]Detection wavelength: 270 nm, 220 nm; column temperature: 25 ° C; injection volume: 20μL

[0017]The mobile phase A is 0.02 mol / L dihydrogen potassium (adjusted pH to 3.2), and the mobile phase B is acetonitrile, and the linear gradient elution is performed in the table:

[0018]

[0019](1) Determination of the concentration of the solution of the substance

[0020]Take the right amount of this product, grind into fine powder, accurately weigh (about 25mg of tribe), set 50mL volumetric flask, add appropriate amount of methanol ultrasound to help, add methanol to the scale, shake, filter The filtrate is taken as a test solution, and 20 μl of the test solution is taken, and the liquid chromatography is injected into the liquid chromatography. The experimental results show that when the sample concentration is 0.5 mg / ml, it can meet the effective detection of impurities, and therefore, the conc...

Embodiment 2

[0023]Example 2 destructive test

[0024]Take the appropriate amount of powder fine, with high temperature, acid, alkali, oxidation, lighting, etc., for discrete conditions, to test the product, to examine whether the selected chromatographic conditions can detect the pallets. The resulting degradation product, the detection wavelength is 220 nm and 270 nm, the specifically as follows:

[0025]1 Unexpected: Take the right amount of this product (about 25mg of the tross), precision weighing, set 50mL volumetric flask, add methanol to dissolve and dilute to the scale, shake, filter,

[0026]2 high temperature damage (solid): Take the right amount of this product, then heating in an oven at 105 ° C for 24 hours, cool, precisely (about 25mg of Trib), set 50mL volumetric flask, add methanol ultrasound Dissolve and dilute to the scale, shake well, filter it,

[0027]3 high temperature damage (liquid): Take the right amount of this product fine powder, precision weighing (about 25mg of the Cheter), se...

Embodiment 3

[0033]Example 3 Stability test of the test solution

[0034]Take the right amount of this product fine powder, add methanol, ultrasonic dissolved and dilute to prepare a solution containing 0.5 mg of the tribe in each 1 ml as the test solution. The post-sample analysis of 0H, 2H, 4H, 6H, 8H, and the stability of the sample solution was found, and the results were shown in Table 1.

[0035]Table 1 Stability test results of the sample solution

[0036]

[0037]The test results show that the product sample solution is placed in 8 hours within 8 hours.

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Abstract

The invention discloses a method for determining related substances of a new drug topiroxostat tablet, which uses high performance liquid chromatography to determine the related substances of the newdrug topiroxostat tablet to improve the reproducibility and precision so as to better control the impurities of the new drug topiroxostat tablet.

Description

Technical field[0001]The present invention relates to a method of detection of a drug, in particular to the relevant substance measurement method of the new drug traveler, which is a medical technology.Background technique[0002]Uric acid is a normal product of purine nucleotide metabolism. When uric acid is reduced, the increase in uric acid in blood exceeds the normal range of hyperurice, and excessive uric acid is mainly deposited in joints, cartilage, Soft and kidneys, causing synthetic clinical manifestations such as arthritis and kidney lesions, known as gout, so high uric hyperoxide and uric acid are deposited in organ tissue into the basic pathogenesis of gout. The cause of uric acid is relatively complex, which can be divided into two major categories of primary and secondary deductive. With the improvement of people's living standards, the improvement of nutrient conditions, the increase in animal protein, fat, changes in life (drinking, smoking, etc.), the incidence of hyp...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/74G01N30/86
CPCG01N30/06G01N30/74G01N30/8634
Inventor 袁航陈阳生孙桂玉刘晓霞王明刚杜昌余薛文静朱锐
Owner CP PHARMA QINGDAO CO LTD
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