A kind of detection method of isomer impurity content in ticagrelor raw material
A detection method and technology for impurity content are applied in the field of detection of isomer impurity content in ticagrelor raw materials, which can solve the problems of inability to control the introduction of isomer impurities from the raw material, and achieve easy control, simple operation, and detection. low cost effect
Active Publication Date: 2018-02-02
CHENGDU BAIYU PHARMA CO LTD
View PDF4 Cites 0 Cited by
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
[0006] However, there is currently no relevant report on the content of isomer impurities in the raw material of ticagrelor (compound M3), so naturally it is impossible to control the introduction of isomer impurities in ticagrelor starting from the raw material
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 1
[0056] Embodiment 1, the present invention detects the high-performance liquid chromatography method of the isomer impurity in ticagrelor raw material (compound M3)
[0057] Column: AD-H, 4.6mm×250mm, 5μm;
[0058] Mobile phase: n-hexane-ethanol-isopropanol (90:5:5)
[0059] Solvent: mobile phase
[0060] Column temperature: 30°C; flow rate: 1.0ml / min; UV detector (detection wavelength: 254nm).
[0061] Injection volume: 20 μL.
[0062] Detection steps:
[0063] Take an appropriate amount of impurity A reference substance, dissolve it in a solvent, and prepare a solution containing 1 μg of impurity A reference substance per 1 mL.
[0064] Take an appropriate amount of the impurity B reference substance, dissolve it in a solvent, and prepare an impurity B reference substance solution containing 1 μg per 1 mL.
[0065] Take an appropriate amount of ticagrelor raw material M3, dissolve it in ethanol, add solvent to dilute, and prepare a test solution containing about 0.5 m...
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 |
|---|---|---|
| length | aaaaa | aaaaa |
| particle diameter | aaaaa | aaaaa |
| wavelength | aaaaa | aaaaa |
Login to View More
Abstract
The invention discloses a method for detecting the content of an isomer impurity in a compound shown in Formula 1. The method comprises the following steps: a, preparing a reference solution; b, preparing a test sample solution; c, detecting the reference solution and the test sample solution by adopting high-performance liquid chromatography respectively; d, obtaining the content of the isomer impurity in the compound shown in Formula 1 by performing calculation by peak area according to an external standard method or performing calculation according to a standard curve between the peak area and concentration. According to the method for detecting the content of the isomer impurity in the compound shown in Formula 1, the separation degree between a chromatographic peak of the compound shown in Formula 1 and a chromatographic peak of the isomer impurity is high; moreover, the method is convenient to operate, easy to control, low in detection cost and accurate and reliable in detection result, an effective detection method is provided for monitoring the product quality of the compound shown in Formula 1, and the product quality of ticagrelor and the medication safety of a patient are further ensured.
Description
technical field [0001] The invention belongs to the field of analysis and detection in chemistry, and in particular relates to a method for detecting the content of isomer impurities in ticagrelor raw materials. Background technique [0002] It is well known in the art that impurities in drugs are the main factors affecting the purity of drugs. If the impurities contained in drugs exceed the limit requirements specified in the quality standards, it is very likely to cause changes in the appearance and physical and chemical parameters of the drug, and even affect the stability of the drug. property, reducing drug activity and increasing toxic and side effects, seriously endangering drug product quality and drug safety of patients; at the same time, the sources of impurities in drugs are very extensive, which may come from the production process or storage process. Among them, production The raw material impurity in the process is a very important source (see: Editor-in-Chief ...
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): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 刘霞林正茂
Owner CHENGDU BAIYU PHARMA CO LTD