Eureka AIR delivers breakthrough ideas for toughest innovation challenges, trusted by R&D personnel around the world.

Method for detecting N-(2-nitrobenzyl)-N-methylcyclohexylamine in bromhexine hydrochloride inhalation solution

A technology of methylcyclohexylamine and bromhexine hydrochloride, applied in the field of drug analysis, achieves the effects of simple operation, accurate detection results and good stability

Active Publication Date: 2020-07-10
南京华盖制药有限公司
View PDF2 Cites 0 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no relevant detection method for this compound reported in the literature at present, so it is urgent to establish a simple operation, accurate result, high sensitivity, which can be used for the genotoxic impurity N-(2-nitrobenzyl)-N- in bromhexine hydrochloride inhalation solution. Method for Determination of Residual Content of Methylcyclohexylamine

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 detecting N-(2-nitrobenzyl)-N-methylcyclohexylamine in bromhexine hydrochloride inhalation solution
  • Method for detecting N-(2-nitrobenzyl)-N-methylcyclohexylamine in bromhexine hydrochloride inhalation solution
  • Method for detecting N-(2-nitrobenzyl)-N-methylcyclohexylamine in bromhexine hydrochloride inhalation solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0043] 1. Experimental part

[0044] 1.1 Solution preparation

[0045] Blank solution preparation: Measure 750mL of purified water and 500mL of acetonitrile, and mix them by ultrasonic to make a blank solution.

[0046] Preparation of the test solution: bromhexine hydrochloride solution for inhalation.

[0047] Reference substance stock solution: Take 2.049mg N-(2-nitrobenzyl)-N-methylcyclohexylamine standard substance into a 10mL volumetric flask, dissolve it with blank solution, dilute to the mark, shake well, and use as N-( 2-nitrobenzyl)–N-methylcyclohexylamine stock solution.

[0048] 1.2 Methodological investigation

[0049] 1.2.1 Specificity experiment

[0050] Get the blank solution, the test solution, and the reference substance stock solution, and inject samples to collect the chromatograms respectively. The results are shown in Figure 1 ~ Figure 3 . The test results show that the blank solution has no interference, and other peaks in the test solution have no...

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

PropertyMeasurementUnit
Concentrationaaaaaaaaaa
Login to View More

Abstract

The invention relates to the technical field of pharmaceutical analysis, in particular to a method for detecting N-(2-nitrobenzyl)-N-methylcyclohexylamine in a bromhexine hydrochloride inhalation solution, which comprises the following steps: preparing a test solution and a reference stock solution; respectively injecting the test solution and the reference stock solution with a certain concentration gradient, performing detection by using a high performance liquid chromatograph, and recording a chromatogram; carrying out linear regression analysis on each mass concentration of the reference stock solution and the peak area of the chromatogram to obtain a regression equation and a correlation coefficient, and making a standard curve; and calculating the content of the N-(2-nitrobenzyl)-N-methylcyclohexylamine according to an external standard method by utilizing the peak area of the N-(2-nitrobenzyl)-N-methylcyclohexylamine in the chromatogram of the test solution. According to the detection method provided by the invention, the sample treatment process is simple to operate, the detection result is accurate, the sensitivity is high and the stability is good.

Description

technical field [0001] The invention relates to the technical field of drug analysis, in particular to a method for detecting N-(2-nitrobenzyl)-N-methylcyclohexylamine in bromhexine hydrochloride inhalation solution. Background technique [0002] N-(2-nitrobenzyl)–N-methylcyclohexylamine, chemical name N-cyclohexyl-N-methyl-o-nitrobenzylamine, is a typical nitrogen oxide free radical, mainly used as a medicine for bromhexine hydrochloride intermediate. Bromhexine hydrochloride is semi-synthesized from anthocyanin extracted from plants. This drug ingredient can break and reduce mucopolysaccharide fibers in human sputum, reduce the viscosity of human sputum, and make it easy for patients to cough up sputum. . The structure of N-(2-nitrobenzyl)–N-methylcyclohexylamine is as follows: [0003] [0004] However, based on the structural toxicity correlation theory, N-(2-nitrobenzyl)–N-methylcyclohexylamine is a potential genotoxic impurity. According to the requirements of th...

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): G01N30/02G01N30/86
CPCG01N30/02G01N30/8679G01N2030/047
Inventor 周鑫张冠军许娜娜孙向阳
Owner 南京华盖制药有限公司
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
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