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
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  • 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 f...

Method used

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  • 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...

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PUM

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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

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Application Information

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IPC IPC(8): G01N30/88
Inventor 牟立燕刘秋叶
Owner AVENTIS PHARMA HAINAN
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