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

Method for separating and determining rivaroxaban related substances through liquid chromatography

A technology of rivaroxaban and determination method, applied in the field of analytical chemistry, can solve the problems affecting the purity and quality of drugs, and achieve the effect of quality control and quality assurance

Inactive Publication Date: 2016-01-20
AVENTIS PHARMA HAINAN
View PDF5 Cites 12 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Incomplete removal of impurities in rivaroxaban will be introduced into the final product of the raw material drug, thereby affecting the purity and quality of the drug

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 separating and determining rivaroxaban related substances through liquid chromatography
  • Method for separating and determining rivaroxaban related substances through liquid chromatography
  • Method for separating and determining rivaroxaban related substances through liquid chromatography

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] High performance liquid chromatography: Shimadzu: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp;

[0043] Column: C 18 (Kromasil, 250×4.6mm, 5μm);

[0044] Mobile phase A: 20mmol / L diammonium hydrogen phosphate-20mmol / L sodium octane sulfonate buffer solution (pH3.0)

[0045] Mobile Phase B: Acetonitrile

[0046] Flow rate: 1.0mL / min

[0047] Detection wavelength: 210nm

[0048] Column temperature: 40°C

[0049] Injection volume: 10μL

[0050] Gradient condition:

[0051] T 0 10 25 60 70 71 80 B% 8 8 18 30 30 8 8

[0052] Experimental procedure

[0053] Take an appropriate amount of rivaroxaban and its related substances, dissolve the samples in acetonitrile respectively, and prepare a sample solution containing about 1.0 mg / mL of rivaroxaban and its related substances. Take an appropriate amount of the above-mentioned rivaroxaban and its related substance solutions, and prepare a system suitability solution; carry out high-per...

Embodiment 2

[0056] High performance liquid chromatography: Shimadzu: LC-20AT, CBM-20A, SIL-20AC, SPD-M20A, CTO-10ASvp;

[0057] Column: C 18 (Kromasil, 250×4.6mm, 5μm);

[0058] Mobile phase A: 20mmol / L diammonium hydrogen phosphate-20mmol / L sodium octane sulfonate buffer solution (pH3.0)

[0059] Mobile Phase B: Methanol

[0060] Flow rate: 1.0mL / min

[0061] Detection wavelength: 210nm

[0062] Column temperature: 40°C

[0063] Injection volume: 10μL

[0064] Gradient condition:

[0065] T 0 10 25 60 70 71 80 B% 30 30 34 40 40 30 30

[0066] Experimental procedure

[0067] Take an appropriate amount of rivaroxaban and its related substances, dissolve the samples in acetonitrile respectively, and prepare a sample solution containing about 1.0 mg / mL of rivaroxaban and its related substances. Take an appropriate amount of the above-mentioned rivaroxaban and its related substance solutions, and prepare a system suitability solution; carry out high-perfo...

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 belongs to the field of analytical chemistry, and discloses a method for separating and determining rivaroxaban related substances and the content thereof through liquid chromatography. The method is characterized in that the content of rivaroxaban and related substances thereof can be quantitatively determined through using a chromatographic column with octadecylsilane chemically bonded silica as a packing material and using a certain ratio of buffer salt solution-organic phase as a mobile phase, so the quality of rivaroxaban can be effectively controlled. The method has the advantages of strong specificity, high accuracy and simple operation.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, in particular to a method for separating and measuring rivaroxaban and its related substances by liquid chromatography. Background technique [0002] Rivaroxaban is clinically used in adult patients undergoing elective hip or knee replacement surgery to prevent venous thrombosis. The drug has the advantages of high safety, oral administration, no cross-resistance, and small adverse reactions. Rivaroxaban chemical name: 5-Chloro-thiophene-2-carboxylic acid{2-oxo-3-[4-(3-oxo-morpholin-4-yl)-phenyl]-oxazolidin-5-yl-methyl} -amide, the molecular formula is C 19 h 18 ClN 3 o 5 S. The structural formula of rivaroxaban is: [0003] [0004] During the production process of rivaroxaban, some important intermediates may be incompletely removed, thereby affecting the purity and quality of the drug; Degradation under special conditions produces degraded impurities; the above-mentioned related ...

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): G01N30/88
Inventor 牟立燕刘秋叶
Owner AVENTIS PHARMA HAINAN
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