A method for the separation and determination of related substances in rivaroxaban intermediates by HPLC
A related substance, rivaroxaban technology, applied in the field of analytical chemistry, can solve the problems of no fast, simple and accurate analysis and detection, and achieve the effect of high sensitivity, convenient operation and strong accuracy
Active Publication Date: 2022-05-31
安徽联创生物医药股份有限公司
View PDF0 Cites 0 Cited by
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
In the existing technology, there is no analytical method suitable for rapid, simple and accurate analysis and detection of related substances in rivaroxaban intermediates
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 moreImage
Smart Image Click on the blue labels to locate them in the text.
Smart ImageViewing Examples
Examples
Experimental program
Comparison scheme
Effect test
Embodiment 3
[0102] Column temperature: 30°C
[0104] Detection wavelength: 220nm
[0105] Injection volume: 10 μl
[0108]
[0119]
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
| Property | Measurement | Unit |
|---|---|---|
| wavelength | aaaaa | aaaaa |
| wavelength | aaaaa | aaaaa |
| particle diameter | aaaaa | aaaaa |
Login to View More
Abstract
The invention provides a method for separating and measuring related substances of rivaroxaban intermediates by HPLC, comprising the following steps: using octadecylsilane bonded silica gel as a filler, and using 0.01-0.03mol / L potassium dihydrogen phosphate solution (Use sodium hydroxide to adjust the pH value to 5.0~8.0) as mobile phase A, acetonitrile or methanol or acetonitrile-methanol as mobile phase B for gradient elution, the flow rate is 0.8~1.2ml / min, and the column temperature is 25~40°C , using an ultraviolet detector to detect the related substances of the rivaroxaban intermediate. The method of the present invention achieves the optimization of the detection results by comprehensively considering the comprehensive influence of the analytical column, mobile phase, gradient elution program, flow rate and column temperature on the separation and detection, and has the advantages of quickness, simplicity, high sensitivity, accuracy and reliability, and wide applicability. Advantages, it is suitable for the separation and determination of related substances of rivaroxaban intermediates, so as to effectively control the quality of medicines.
Description
A method for separating and determining rivaroxaban intermediate related substances by HPLC technical field The present invention relates to analytical chemistry technical field, be specifically related to a kind of HPLC separation and determination of rivaroxaban intermediate has method of matter. Background technique Rivaroxaban (Rivaroxaban, trade name Xarelto), is jointly developed by Bayer and Johnson & Johnson A small molecule oral anticoagulant, approved by the U.S. Food and Drug Administration (FDA) on July 1, 2011. For the prevention of deep vein thrombosis in patients undergoing knee or hip replacement surgery. (S)-N-glycidyl phthalimide is Rivaroxaban intermediate, molecular formula: C 11 H 9 NO 3 , molecular weight: 203.19, the chemical structural formula is as follows (1): [0004] This intermediate, in preparation process, produces a plurality of impurities due to various factors such as starting material, synthesis technique, degradatio...
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
Login to View More Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/34G01N30/36G01N30/60G01N30/74G01N30/86
CPCG01N30/02G01N30/34G01N30/36G01N30/74G01N30/60G01N30/06G01N30/8679
Inventor 吴其华葛德培陈海兵李强邵广晴
Owner 安徽联创生物医药股份有限公司