Method for detecting hydroxychloroquine sulfate related substances and application thereof

A technology of hydroxychloroquine sulfate and a detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of less detection of impurities, low sensitivity, and low specificity, and achieve fast analysis speed, good separation effect, and no The effect of blank interference

Active Publication Date: 2020-08-18
SHANGHAI ZHONGXI SUNVE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In order to solve the problems of low specificity, low sensitivity and few detectable impurities in the detection method in the

Method used

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  • Method for detecting hydroxychloroquine sulfate related substances and application thereof
  • Method for detecting hydroxychloroquine sulfate related substances and application thereof
  • Method for detecting hydroxychloroquine sulfate related substances and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] (1) Chromatographic conditions:

[0040] Stationary phase: octylsilane bonded silica silane bonded silica; (manufacturer Agilent, model ZORBAX ExtendC8, 5um, 4.6x150mm)

[0041] The length of the chromatographic column is 150mm;

[0042] Mobile phase: Mobile phase A (buffer solution): 0.01mol / L ammonium acetate aqueous solution, adjust pH to 9.0 with 100% triethylamine solution; Mobile phase B (water-soluble organic solvent): methanol: acetonitrile=80:20 ( V / V).

[0043] Gradient elution according to the following program:

[0044] time (min) Mobile phase A(%) Mobile phase B(%) 0 55 45 3 55 45 15 50 50 36 30 70 37 55 45 45 55 45

[0045] Flow rate: 0.8mL / min; detection wavelength: 254nm

[0046] Column temperature: 35°C; Injection volume: 10μl

[0047] (2) Preparation of mixed impurity reference substance solution:

[0048] Take by weighing hydroxychloroquine sulfate reference substance and each component impurit...

Embodiment 2

[0054] (1) Chromatographic conditions:

[0055] Stationary phase: octadecylsilane bonded silica silane bonded silica; (manufacturer Agilent, model ZORBAX ExtendC8, 5um, 4.6x150mm)

[0056] The length of the chromatographic column is 150mm;

[0057] Mobile phase: Mobile phase A (buffer solution): 0.05mol / L ammonium acetate aqueous solution, adjust pH to 10.5 with 100% triethylamine solution; Mobile phase B (water-soluble organic solvent): methyl alcohol: acetonitrile: Virahol = 70:20:10 (V / V)

[0058] Gradient elution according to the following program:

[0059] time (min) Mobile phase A(%) Mobile phase B(%) 0 55 45 3 55 45 15 50 50 36 30 70 37 55 45 45 55 45

[0060] Flow rate: 0.8mL / min; detection wavelength: 254nm

[0061] Column temperature: 35°C; Injection volume: 10μl

[0062] (3) Preparation of mixed impurity reference substance solution:

[0063] Take by weighing hydroxychloroquine sulfate reference substance a...

Embodiment 3

[0084] The difference between embodiment 3 and embodiment 1 is only: gradient elution according to the following procedure:

[0085] time (min) Mobile phase A(%) Mobile phase B(%) 0 57 43 3 57 43 15 50 50 36 32 68 37 57 43 45 57 43

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Abstract

The invention discloses a method for detecting hydroxychloroquine sulfate related substances. The method comprises the following step: carrying out separation and detection by adopting reverse liquidchromatography, wherein chromatographic conditions are as follows: a mobile phase is a mixed solvent consisting of a water-soluble organic solvent and a buffer solution; wherein the buffer solution isan ammonium acetate solution or an ammonium formate solution; wherein the pH value of the buffer solution is 9.0 to 10.5. The detection method disclosed by the invention can be used for simultaneously detecting seven impurities recorded in quality standards of hydroxychloroquine sulfate raw materials in European Pharmacopoeia 9.8 versions in hydroxychloroquine sulfate raw materials and preparations, and has the advantages of good separation effect, high sensitivity, no blank interference, low detection cost, high analysis speed and the like.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a method for detecting related substances of hydroxychloroquine sulfate and an application thereof. 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 both in the raw material drug and the preparation. [0005] At present, in the current national standard of raw material of hydroxychloroquine sulfate—Ministry of Health Drug Standards (Part II) Volume I E1-97, the detection method of related substances is thin-layer chromatography, which has the problems of low specificity...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/86
CPCG01N30/02G01N30/06G01N30/34G01N30/8675
Inventor 颜国明汪青青陈春燕李杰袁少卿尹超
Owner SHANGHAI ZHONGXI SUNVE PHARMA
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