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Method for separating and measuring rivaroxaban and its impurities, and application thereof

A technology of rivaroxaban and determination method, which is applied in the field of analytical chemistry, can solve the problems affecting the accuracy of impurity extraction method and the extraction of impurity H, and achieve the effect of simple and feasible method, high accuracy, precision and high sensitivity

Active Publication Date: 2018-04-20
CHONGQING HUAPONT PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The diluent and impurity H produce a solvent effect, which affects the extraction of impurity H, thereby affecting the accuracy of the impurity extraction method
[0008] Therefore, so far, there is no published method report that can stably, accurately and comprehensively determine the simultaneous separation of rivaroxaban and its preparation impurities.

Method used

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  • Method for separating and measuring rivaroxaban and its impurities, and application thereof
  • Method for separating and measuring rivaroxaban and its impurities, and application thereof
  • Method for separating and measuring rivaroxaban and its impurities, and application thereof

Examples

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Embodiment 1

[0054] Method for separation and determination of rivaroxaban and its impurities

[0055] 1. Instruments and conditions

[0056] Instrument: high performance liquid chromatography;

[0057] Chromatographic column: use octadecylsilane bonded silica gel as filler, Agilent Eclipe XDB-C18, 250mm×4.6mm, 5μm or a chromatographic column with equivalent performance;

[0058] Detector detection wavelength: 250nm;

[0059] Mobile phase flow rate: 1.5ml / min;

[0060] Mobile phase A: Take 1.0mol / L sodium dihydrogen phosphate solution (adjust the pH value to 3.0 with phosphoric acid) 10ml, add water to 900ml, shake well, add 50ml methanol and 50ml acetonitrile;

[0061] Mobile phase B: Take 1.0mol / L sodium dihydrogen phosphate solution (adjust the pH value to 3.0 with phosphoric acid) 10ml, add water to 300ml, shake well, add 700ml acetonitrile;

[0062] Diluent 1: acetonitrile-0.2mol / L phosphoric acid solution-water (300:10:690);

[0063] Diluent 2: acetonitrile-0.2mol / L phosphoric aci...

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Abstract

The invention belongs to the field of analytical chemistry, and concretely relates to a method for separating and measuring rivaroxaban and its impurities, and an application thereof. A reagent composition for separating and measuring rivaroxaban and its impurities comprises: a diluent which is an aqueous solution of acetonitrile and an acid; a mobile phase A which is a buffer salt solution containing methanol and acetonitrile; and mobile phase B which is a mixture of the buffer salt solution and acetonitrile. The method for separating and measuring rivaroxaban and its impurities by using thereagent composition comprises the following steps: dissolving rivaroxaban in the diluent to obtain a sample solution; preparing the mobile phases; injecting the sample solution into a separation and detection system, and eluting and separating the sample solution with the mobile phases to obtain an eluate; and adding the eluate into a detector, and measuring the eluate. The method has the advantages of realization of complete separation of the rivaroxaban and its impurities, good baseline, high sensitivity, short analysis time, good reappearance, and realization of effective separation and themeasurement of the content of every relevant substance in a rivaroxaban raw medicine and a rivaroxaban preparation.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, in particular to a method and application for separating and measuring rivaroxaban and its impurities. Background technique [0002] Rivaroxaban is an oral anticoagulant that directly inhibits factor Xa with high selectivity, and its molecular formula is C 19 h 18 ClN 3 o 5 S, chemical name: 5-chloro-N-({(5S)-2-oxo-3-[4-(3-oxo-4-morpholinyl)-phenyl]-1,3-oxo Oxazolidine-5-yl}-methyl)-2-thiophene-carboxamide, its structural formula is: [0003] [0004] In the process of synthesizing rivaroxaban, some intermediates of known structures and unknown impurities remain due to incomplete removal, which affects the purity and quality of rivaroxaban. These intermediates of known structures and impurities of unknown structures and The degradation products of varoxaban are collectively referred to as related substances (ie, impurities) in drug quality control. These impurities should be controlle...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 周维唐朝军兰昌云陈雯
Owner CHONGQING HUAPONT PHARMA
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