S-hydroxychloroquine sulfate isomer inspection method

A technology of hydroxychloroquine sulfate and testing method, applied in the directions of measuring devices, instruments, scientific instruments, etc., can solve problems such as the detection method of less S-hydroxychloroquine sulfate isomers

Inactive Publication Date: 2021-03-16
珠海润都制药股份有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0004] At present, there are few reports on the detection method of S-hydroxychloroquine sulfate isomers, the present invention discloses the detection method of S-hydroxychloroquine sulfate isomers for the first time, for solving the detection problem of S-hydroxychloroquine sulfate isomers, provides A convenient, efficient and accurate detection method, which can detect the content of S-hydroxychloroquine sulfate isomers, thereby effectively ensuring drug safety and facilitating the quality control of S-hydroxychloroquine sulfate raw materials

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0025] (1) Preparation solution: blank solution: mobile phase;

[0026] The mobile phase is: 0.1mol / l ammonium acetate solution: isopropanol=94:6 (V / V);

[0027] The system suitability solution: take about 5 mg of hydroxychloroquine sulfate reference substance, put it in a 100ml volumetric flask, add an appropriate amount of blank solution and dilute to the mark, and shake well; (concentration: 0.05mg / ml)

[0028] The reference solution: take about 30 mg of R-hydroxychloroquine sulfate reference substance, accurately weigh it, place it in a 50 ml volumetric flask, add an appropriate amount of blank solution to dissolve and dilute to the mark, shake well; accurately measure 1.0 ml, and place it in a volume of 100 ml In the bottle, add an appropriate amount of blank solution to dissolve and dilute to the mark, and shake well. (Concentration: 6μ / ml)

[0029] The test solution: take about 30 mg of S-hydroxychloroquine sulfate sample, accurately weigh it, place it in a 100 ml vol...

Embodiment 2

[0037] Example 2: System Suitability

[0038] System suitability is achieved by measuring the separation between R-hydroxychloroquine sulfate and S-hydroxychloroquine sulfate in the system suitability solution, and the separation between R-hydroxychloroquine sulfate and S-hydroxychloroquine sulfate should be ≥ 1.5 .

Embodiment 3

[0039] Example 3: Specificity

[0040] Specificity is achieved by measuring whether the blank solution interferes with the detection of R-hydroxychloroquine sulfate and the separation between R-hydroxychloroquine sulfate and adjacent component peaks in the test solution; There should be no interference in the detection, and the separation between R-hydroxychloroquine sulfate and adjacent component peaks in the test solution should be ≥ 1.5.

[0041]

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Abstract

The invention belongs to the technical field of pharmaceutical analysis, particularly relates to a detection method of a S-hydroxychloroquine sulfate isomer, and provides a convenient, efficient and accurate detection method in order to solve the detection problem of the S-hydroxychloroquine sulfate isomer, and the method can detect the content of the S-hydroxychloroquine sulfate isomer, so that the medication safety is effectively guaranteed and the quality control of hydroxychloroquine sulfate bulk drug is facilitated. The method is convenient, efficient and accurate, completely conforms tothe guidance principle verified by the Chinese pharmacopoeia method in the aspects of system applicability, repeatability, specificity and accuracy, and can be used for quality control of the hydroxychloroquine sulfate bulk drug.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, in particular to a method for testing S-hydroxychloroquine sulfate isomers. Background technique [0002] Hydroxychloroquine sulfate, the structural formula is: , chemical name: (±)-2[[4-[(7-chloro-4-quinolyl)amino]phenyl]-ethylamino]ethanol sulfate, first listed in the United States in 1956, is an anti Malaria drug, clinically used for rheumatoid arthritis, juvenile chronic arthritis, discoid and systemic lupus erythematosus, and skin lesions caused or exacerbated by sunlight. [0003] S-Hydroxychloroquine sulfate, chemically named as (S)-(+)-2-[[4-[(7-chloro-4-quinolyl)amino]pentyl]ethylamino]-ethanol sulfate, chemical structure: , R-hydroxychloroquine sulfate, chemically named as (R)-(-)-2-[[4-[(7-chloro-4-quinolyl)amino]pentyl]ethylamino]-ethanol sulfate, Chemical Structure: . In the process of splitting hydroxychloroquine sulfate to obtain S-hydroxychloroquine, there will be S...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 吴挺强谢金昌汤伟彬兰柳琴
Owner 珠海润都制药股份有限公司
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