Method for determining organic impurities in hydroxychloroquine sulfate

A technology of hydroxychloroquine sulfate and organic impurities, applied in the field of drug analysis, can solve the problems of low sensitivity, missed detection of impurities, weak specificity of TLC method, etc., and achieve the effect of quality control and strong specificity

Inactive Publication Date: 2020-07-31
CHANGSHA RUHONG MEDICINE TECH CO LTD +1
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0005] The technical problem to be solved by the present invention is to overcome the shortcomings of the existing TLC method, such as low specificity, low sensitivity, and inability to accurately quantify, and at the same time overcome the shortcomings of the existing HPLC method for missing impurities, and to provide a TLC method with strong specificity and no missing detection. The HPLC method of impurity is used for the quantitative determination of organic impurity content in hydroxychloroquine sulfate crude drug and preparation

Method used

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  • Method for determining organic impurities in hydroxychloroquine sulfate
  • Method for determining organic impurities in hydroxychloroquine sulfate
  • Method for determining organic impurities in hydroxychloroquine sulfate

Examples

Experimental program
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Embodiment

[0022] Example Determination of actual samples

[0023] (1) Use of instruments and reagents

[0024] Agilent technologies 1100 Series quaternary low-pressure liquid chromatograph (VWD detector), SartoriusBT25S and Sartorius BSA124S electronic balances, Shanghai Leici PHSJ-3F pH meter.

[0025] Glacial acetic acid (≥99.5%) and ammonia water (25%) are AR grade, acetonitrile is HPLC grade, water is China Resources C’estbon purified water, hydroxychloroquine sulfate (batch number: HCQ-20200428-01) is produced by Changsha Ruhong Pharmaceutical Technology Co., Ltd. Inc. provided.

[0026] (2) Chromatographic determination conditions

[0027] Chromatographic column: ACE Excel 5 Super C18, 4.6×150mm;

[0028] Column temperature: 30°C; Injection volume: 10ul; Flow rate: 1.0ml / min; Detection wavelength: 220nm;

[0029] Mobile phase A: NH at pH 10.0 3 -NH 4 + ; Mobile phase B: ammonia-acetonitrile solution.

[0030] The mobile phase was gradient eluted from mobile phase A and mob...

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Abstract

The invention discloses a method for determining organic impurities in hydroxychloroquine sulfate. According to the method, a chromatographic column taking octadecylsilane chemically bonded silica asa filler is adopted, a diode array detector or an ultraviolet detector is used as a detector, the mobile phase is subjected to gradient elution by a mobile phase A (NH3-NH4 < + > buffer solution) anda mobile phase B (ammonia water-acetonitrile mixed solution), the elution procedure (the volume ratio of A to B at different times) is as follows: 0 min (65: 35), 15 min (65: 35), 16 min (35: 65), 30min (35: 65), 30.01 min (65: 35) and 40 min (65: 35). The method is high in specificity and can be used for rapidly detecting the organic impurities in the hydroxychloroquine sulfate.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for determining organic impurities in hydroxychloroquine sulfate. 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-quinolyl)amino]pentyl]ethylamino]-ethanol sulfate. In order to ensure drug safety, organic impurities in raw materials or preparations need to be strictly controlled. At present, the national standards and ministerial standards of the People's Republic of China, the United States Pharmacopoeia USP40 and the 10th edition of the Korean Pharmacopoeia all use thin-layer chromatography (TLC method). After research, it is found that when using TLC method to detect organic impurities in hydroxychloroquine sulfate, there are problems of low specificity and low sensi...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/60
CPCG01N30/02G01N30/60
Inventor 吉丹丹薛琳唐亮
Owner CHANGSHA RUHONG MEDICINE TECH CO LTD
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