Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

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
View PDF6 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • 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
Comparison scheme
Effect test

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...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): G01N30/02G01N30/60
CPCG01N30/02G01N30/60
Inventor 吉丹丹薛琳唐亮
Owner CHANGSHA RUHONG MEDICINE TECH CO LTD
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com