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Method for detecting content of hydroxychloroquine sulphate impurities in hydroxychloroquine sulfate

A technology of hydroxychloroquine sulfate and hydroxychloroquine sulfate, which is applied in the field of detecting the impurity content of hydroxychloroquine sulfate in hydroxychloroquine sulfate, can solve problems such as impurity control, and achieve fast determination speed, good reproducibility and high accuracy Effect

Inactive Publication Date: 2021-02-23
GUANGDONG NEWSOUTH ARTEPHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

At present, the inspection method for related substances in the current quality standard of hydroxychloroquine sulfate raw material is still thin-layer chromatography, and it is impossible to control its impurities to a certain extent

Method used

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  • Method for detecting content of hydroxychloroquine sulphate impurities in hydroxychloroquine sulfate
  • Method for detecting content of hydroxychloroquine sulphate impurities in hydroxychloroquine sulfate
  • Method for detecting content of hydroxychloroquine sulphate impurities in hydroxychloroquine sulfate

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Embodiment

[0044] In a specific embodiment, the method for detecting hydroxychloroquine sulfate impurity content in hydroxychloroquine sulfate comprises the following steps:

[0045] 1. Preparation of the test solution

[0046] Get 10 mg of hydroxychloroquine sulfate, accurately weighed, put in a 100ml measuring bottle, add mobile phase A [acetonitrile: water (10:90) (containing 0.2% phosphoric acid)] to make a solution containing about 0.1 mg of hydroxychloroquine sulfate in every 1 ml , filter, get the continued filtrate as need testing solution; precision measures need testing solution 1ml, adds mobile phase A and makes the solution that contains hydroxychloroquine sulfate 0.5 μ g in every 1ml approximately, as contrast solution (0.5%); Take an appropriate amount of contrast solution, add mobile phase A to make a solution containing about 0.05 μ g of hydroxychloroquine sulfate in every 1 ml, as the reporting limit solution (0.05%), in the chromatogram of the test solution, the peak th...

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Abstract

The invention relates to a method for detecting the content of hydroxychloroquine sulphate impurities in hydroxychloroquine sulfate. The method comprises the following steps: performing detecting by using a liquid chromatography under the following detection conditions: a chromatographic column is a phenyl chromatographic column, the mobile phase is composed of 0.05 mol / L of potassium dihydrogen phosphate solution and methanol, the 0.05 mol / L of potassium dihydrogen phosphate solution is used as a mobile phase A, and the methanol is used as a mobile phase B, and the volume ratio of the mobilephase A to the mobile phase B is 80: 20. The method has a high degree of separation for hydroxychloroquine sulphate.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, and in particular relates to a method for detecting the impurity content of hydroxychloroquine sulfate in hydroxychloroquine sulfate. Background technique [0002] Hydroxychloroquine sulfate is white or off-white crystalline powder; odorless, bitter taste. Soluble in water, almost insoluble in ethanol, chloroform or ether. Its molecular structural formula is as follows: [0003] [0004] Hydroxychloroquine sulfate is often used as an antimalarial drug for controlling malaria symptoms and suppressive prevention of malaria symptoms. It can also be used for rheumatoid arthritis and lupus erythematosus. At present, the inspection method for related substances in the current quality standard of hydroxychloroquine sulfate raw material is still thin-layer chromatography, and it is impossible to control its impurities to a certain extent. [0005] With reference to US2546658 and WO201...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8679G01N2030/027
Inventor 宋健平徐勤王琪员月明郑绍琴
Owner GUANGDONG NEWSOUTH ARTEPHARM CO LTD
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