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Method for analysis of hydroxychloroquine sulfate raw material and preparation by high performance liquid chromatography

A technology of high performance liquid chromatography and hydroxychloroquine sulfate, which is applied in the direction of analyzing materials, material separation, measuring devices, etc., can solve the problems of low specificity and low sensitivity, and achieve the effect of overcoming low specificity

Inactive Publication Date: 2013-12-25
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The invention overcomes the disadvantages of the existing detection methods, such as low specificity, low sensitivity and the use of toxic reagents

Method used

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  • Method for analysis of hydroxychloroquine sulfate raw material and preparation by high performance liquid chromatography
  • Method for analysis of hydroxychloroquine sulfate raw material and preparation by high performance liquid chromatography
  • Method for analysis of hydroxychloroquine sulfate raw material and preparation by high performance liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Use octylsilane bonded silica gel as filler, use phosphate buffer solution (take 2.72g of potassium dihydrogen phosphate, put it in 1000ml of water, add 2ml of triethylamine, adjust the pH to 8.0±0.05 with 1mol of potassium hydroxide as mobile phase A, Methanol is the mobile phase B, carry out gradient elution according to the following table:

[0024] time (minutes)

Mobile Phase A (V / V)

Mobile phase B (V / V)

0～20

53→33

47→67

20～32

33

67

[0025] The detection wavelength is 254nm. The number of theoretical plates should not be less than 2000 based on the peak of hydroxychloroquine sulfate.

[0026] Get an appropriate amount of hydroxychloroquine sulfate crude drug, add solvent [mobile phase A-methanol (53:47)] to dissolve and dilute to make a solution containing 0.5 mg in every 1 ml as the test solution; accurately measure an appropriate amount, and dilute with the above-mentioned solvent Prepare a solution containi...

specific Embodiment 2

[0028] Use octylsilane bonded silica gel as the filler, and use phosphate buffer solution (take 3.12g of sodium dihydrogen phosphate, put it in 1000ml of water, add 5ml of triethylamine, adjust the pH to 8.0±0.05 with 1mol of potassium hydroxide) as the flow Phase A, acetonitrile as mobile phase B, carry out gradient elution according to the following table:

[0029] time (minutes)

Mobile Phase A (V / V)

Mobile phase B (V / V)

[0030] 0～25

60→20

40→80

25.1～40

20

80

[0031] The detection wavelength is 254nm. The number of theoretical plates should not be less than 2000 based on the peak of hydroxychloroquine sulfate.

[0032] Get an appropriate amount of hydroxychloroquine sulfate raw material, dissolve and dilute with a solvent [mobile phase A-acetonitrile (60:40)] to make a solution containing 0.5 mg in every 1 ml as the test solution; accurately measure an appropriate amount, and dilute with the above-mentioned s...

specific Embodiment 3

[0034] Use octadecylsilane bonded silica gel as filler, and use phosphate buffer solution (take 5.44g of potassium dihydrogen phosphate, put it in 1000ml of water, add 3ml of triethylamine, and adjust the pH value to 8.0± with 1mol / L potassium hydroxide solution 0.05)-methanol (60:40) is the mobile phase, and the detection wavelength is 254nm. The number of theoretical plates should not be less than 2000 based on the peak of hydroxychloroquine sulfate.

[0035] Take an appropriate amount of hydroxychloroquine sulfate crude drug, dissolve and dilute with mobile phase to make a solution containing 0.4 mg per 1 ml as the test solution; accurately measure an appropriate amount, dilute with mobile phase to make a solution containing 4 μg per 1 ml as a contrast solution . Accurately measure 20 μl each of the test solution and the control solution, inject them into the liquid chromatograph, and record the chromatograms. Calculate the content of related substances according to its o...

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Abstract

The invention belongs to the field of drug analysis and discloses a method for analysis of a hydroxychloroquine sulfate raw material and preparation by high performance liquid chromatography. The method can realize effective separation of related substances in hydroxychloroquine sulfate so that hydroxychloroquine sulfate quality is controlled, hydroxychloroquine sulfate raw material and preparation content is accurately determined, and hydroxychloroquine sulfate stability is indicated. The method has the advantages of strong specificity, high accuracy and simple operation.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for analyzing raw materials and preparations of hydroxychloroquine sulfate by high performance liquid chromatography. Background technique [0002] Hydroxychloroquine sulfate is a drug used to treat discoid lupus erythematosus, systemic lupus erythematosus, and rheumatoid arthritis. Its structural formula is: [0003] [0004] The chemical name is 2-[[4-[(7-chloro-4-quinoline)amino]pentyl]ethylamino]-ethanol sulfate. For the related substances introduced in the synthesis of hydroxychloroquine sulfate and degraded during storage, it is necessary to control whether it is in the raw material or the preparation. Therefore, realizing the separation of hydroxychloroquine sulfate and related substances has important practical significance in the synthesis of hydroxychloroquine sulfate and the quality control of the preparation process. [0005] At present, the national standa...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 乔春莲刘莎沈婕杨波
Owner WUHAN WUYAO SCI & TECH
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