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Analysis method for determining rivaroxaban and impurities thereof

An analytical method, the technology of rivaroxaban, applied in the field of analytical chemistry, can solve the problems of high cost of buffer salt solution, blockage of chromatographic column, strict operation requirements, etc., and achieve the effect of strong specificity, elimination of interference, and improvement of durability

Active Publication Date: 2021-06-04
SHANGHAI PUKANG PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0012] It can be seen that in the detection of rivaroxaban and its related journals, the preferred mobile phase is buffered saline solution, but there is a risk of salting out when buffered saline solution is mixed with high-concentration organic phase, and salting out may cause the column Blockage, and the preparation of buffered saline solution is relatively expensive, and the operation requirements are strict

Method used

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  • Analysis method for determining rivaroxaban and impurities thereof
  • Analysis method for determining rivaroxaban and impurities thereof
  • Analysis method for determining rivaroxaban and impurities thereof

Examples

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Embodiment 1

[0057] An analytical method for determining rivaroxaban and its impurities

[0058] 1.1 Preparation of impurity stock solution:

[0059] Take impurity L, impurity A, impurity O, impurity B, impurity C, impurity I, impurity M, impurity K, impurity N, impurity D, impurity E, impurity F, impurity RC18, impurity G, and use solvent [acetonitrile- Water (20:80)] ultrasonically dissolved and quantitatively diluted to a solution of about 20ug / ml.

[0060] 1.2 Preparation of system suitability solution:

[0061] Take about 10mg of rivaroxaban, weigh it accurately, put it in a 50ml volumetric flask, add 10ml of acetonitrile and ultrasonically dissolve it completely, add 1ml of each impurity stock solution, dilute to the mark with a solvent, and shake well.

[0062] 1.3 Preparation of the test solution:

[0063] Take about 85 mg of fine powder of rivaroxaban tablets, weigh it accurately, put it in a 50ml measuring bottle, add 10ml of acetonitrile and sonicate for 15 minutes to dissolv...

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Abstract

The invention relates to the technical field of analytical chemistry, in particular to an analysis method for separating and accurately determining rivaroxaban impurities by adopting high performance liquid chromatography. On the basis of high performance liquid chromatography, the method adopts proper chromatographic conditions and ensures the separation degree of all impurities; and for the impurity N and the impurity K which are difficult to separate under the conditions, the two impurities difficult to separate are accurately quantified through a double-slope-length mode and by combining peak areas of the two impurities under two specific wavelengths and a correction factor relative to a main peak.

Description

technical field [0001] The invention relates to the technical field of analytical chemistry, in particular to an analysis method for separating and accurately determining impurities of rivaroxaban by using high performance liquid chromatography. Background technique [0002] Rivaroxaban is an oral anticoagulant that directly inhibits factor Xa with high selectivity. Rivaroxaban was launched in China in 2014 under the product name The chemical name of rivaroxaban is 5-chloro-N-(((5S)-2-oxo-3-(4-(3-oxomorpholin-4-yl)phenyl)-1,3-oxa Azolin-5-yl)methyl)thiophene-2-carboxamide, the molecular formula is C 19 h 18 ClN 3 o 5 S, the molecular weight is 435.88, the structural formula is as follows: [0003] [0004] There are mainly three approved indications: 1. For adult patients undergoing elective hip or knee replacement surgery to prevent venous thrombosis (VTE); 2. For the treatment of adult deep vein thrombosis (DVT) and pulmonary embolism ( PE), for reducing the ris...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/34G01N30/36G01N30/60G01N30/74
CPCG01N30/02G01N30/34G01N30/36G01N30/6052G01N30/74
Inventor 杨勇赵颖
Owner SHANGHAI PUKANG PHARMA
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