Method for detecting content of rivaroxaban isomer

A technology of rivaroxaban and a detection method, which is applied in the field of analytical chemistry, can solve problems such as low sensitivity and poor durability of chromatographic columns, and achieve the effects of improving sensitivity, accuracy, and signal-to-noise ratio

Pending Publication Date: 2022-04-01
YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the determination of related substances of rivaroxaban mostly adopts high-efficiency forward liquid chromatography, but there are problems of poor column durability and low sensitivity in the detection of rivaroxaban by forward chromatography

Method used

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  • Method for detecting content of rivaroxaban isomer
  • Method for detecting content of rivaroxaban isomer
  • Method for detecting content of rivaroxaban isomer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Prepare the test solution of rivaroxaban: take 640 mg of fine powder of rivaroxaban tablets, which is equivalent to 75 mg of rivaroxaban, wherein the rivaroxaban tablets are provided by Yangzijiang Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd. Accurately weighed and placed in a 50mL measuring bottle, add no more than 50mL of diluent, and perform ultrasonic operation for 25 minutes, then dilute the solution in the volumetric flask to the mark with the diluent, wherein the diluent is acetonitrile aqueous solution, acetonitrile aqueous solution Acetonitrile: water=50:50; then the sample solution in the volumetric flask is shaken up, and the constant volume operation is completed to obtain the test solution containing 1.5 mg of rivaroxaban in every 1 mL.

[0055] Prepare the control solution of rivaroxaban: accurately measure 5mL of the test solution, put it in a 100mL measuring bottle, dilute to the mark with a diluent, shake well, and use it as the control...

Embodiment 2

[0058] Prepare the test solution of rivaroxaban: take 640 mg of fine powder of rivaroxaban tablets, which is equivalent to 75 mg of rivaroxaban, wherein the rivaroxaban tablets are provided by Yangzijiang Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd. Accurately weighed and placed in a 50mL measuring bottle, add no more than 50mL of diluent, and perform ultrasonic operation for 25 minutes, then dilute the solution in the volumetric flask to the mark with the diluent, wherein the diluent is acetonitrile aqueous solution, acetonitrile aqueous solution Acetonitrile: water=50:50; then the sample solution in the volumetric flask is shaken up, and the constant volume operation is completed to obtain the test solution containing 1.5 mg of rivaroxaban in every 1 mL.

[0059] Prepare the control solution of rivaroxaban: accurately measure 5mL of the test solution, put it in a 100mL measuring bottle, dilute to the mark with a diluent, shake well, and use it as the control...

Embodiment 3

[0062] Prepare the test solution of rivaroxaban: take 640 mg of fine powder of rivaroxaban tablets, which is equivalent to 75 mg of rivaroxaban, wherein the rivaroxaban tablets are provided by Yangzijiang Pharmaceutical Group Guangzhou Hairui Pharmaceutical Co., Ltd. Accurately weighed and placed in a 50mL measuring bottle, add no more than 50mL of diluent, and perform ultrasonic operation for 25 minutes, then dilute the solution in the volumetric flask to the mark with the diluent, wherein the diluent is acetonitrile aqueous solution, acetonitrile aqueous solution Acetonitrile: water=50:50; then the sample solution in the volumetric flask is shaken up, and the constant volume operation is completed to obtain the test solution containing 1.5 mg of rivaroxaban in every 1 mL.

[0063] Prepare the control solution of rivaroxaban: accurately measure 5mL of the test solution, put it in a 100mL measuring bottle, dilute to the mark with a diluent, shake well, and use it as the control...

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Abstract

The invention provides a method for detecting the content of rivaroxaban isomers. The method for detecting the content of the rivaroxaban isomer comprises the following steps: preparing a test solution of rivaroxaban; preparing a control solution of the rivaroxaban; the test solution and the control solution are respectively detected and analyzed by adopting a high performance liquid chromatograph, a chromatographic column is a reversed-phase chiral chromatographic column, a mobile phase is acetonitrile, the column temperature is 20-30 DEG C, and the flow velocity is 0.8 mL / min-1. 2 mL / min. The method for detecting the content of the rivaroxaban isomer has the advantages of relatively good durability and relatively high accuracy.

Description

technical field [0001] The invention relates to the technical field of analytical chemistry, in particular to a method for detecting the content of isomers of rivaroxaban. Background technique [0002] Anticoagulant drugs play an important role in the prevention of thrombosis, but traditional anticoagulant drugs such as heparin need parenteral administration, which is inconvenient to use outside the hospital. Oral anticoagulants such as warfarin have a narrow therapeutic window, requiring frequent monitoring of prothrombin time, which brings inconvenience to patients. A new oral anticoagulant, rivaroxaban, is a direct factor Xa inhibitor with the advantages of ease of use and no need for monitoring". Rivaroxaban is highly selective for factor Xa and is used in hip or knee arthroplasty The prevention of post-venous thromboembolism has excellent in vivo activity and bioavailability, and has a good application prospect. [0003] In the process of synthesizing rivaroxaban, the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
Inventor 施猛任亚东夏春森刘志强汪刘恒袁海成
Owner YANGTZE RIVER PHARM GRP GUANGZHOU HAIRUI PHARM CO LTD
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