A kind of detection method of residual solvent in ezetimibe
A technology of ezetimibe and residual solvents, applied in the field of analytical chemistry, can solve the problems of human body influence and limitation of patients, and achieve the effects of good reproducibility and accuracy, low detection limit and good specificity
Active Publication Date: 2017-03-15
LEPU PHARMACEUTICAL CO LTD
View PDF1 Cites 0 Cited by
- Summary
- Abstract
- Description
- Claims
- Application Information
AI Technical Summary
Problems solved by technology
If the residual amount of organic solvent exceeds the safe value, it will have a certain impact on the human body of the patient, so there are strict restrictions on the residual solvent of the drug
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
[0023] A method for detecting residual solvents in ezetimibe, using gas chromatography to simultaneously detect the residual organic solvents in isopropanol, dichloromethane, n-hexane, ethyl acetate and acetic acid 5 in ezetimibe raw materials ,
[0024] Described gas chromatography determination process is as follows:
[0025] 4) Preparation of the reference solution: Take appropriate amount of isopropanol, dichloromethane, n-hexane, ethyl acetate, and acetic acid, weigh them accurately, add dimethyl sulfoxide to dissolve and dilute to make each 1mL of isopropyl alcohol A mixed solution of 0.5 mg of alcohol, 0.06 mg of dichloromethane, 0.029 mg of n-hexane, 0.5 mg of ethyl acetate, and 0.5 mg of acetic acid was used as the reference solution;
[0026] 5) Preparation of the test solution: Take 1.0g of ezetimibe sample, weigh it accurately, put it in a 10mL measuring bottle, add dimethyl sulfoxide to dissolve and dilute to the mark, shake well, and use it as the test solution;...
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
Login to View More Abstract
The invention relates to a detection method for residual solvent in ezetimibe, and belongs to the technical field of analytical chemistry. The gas chromatographic method is adopted, and the detection method includes the steps of 1 reference substance solution preparing, wherein appropriate amount of isopropanol, dichloromethane, normal hexane, ethyl acetate and acetic acid are taken, weighed precisely, added with dimethyl sulfoxide to be dissolved and diluted so as to prepare a mixed solution serving as a reference substance solution, and one ml of the mixed solution contains 0.5 mg of isopropanol, 0.06 mg of dichloromethane, 0.029 mg of normal hexane, 0.5 mg of ethyl acetate and 0.5 mg of acetic acid; 2 test solution preparing, wherein 1.0 g of ezetimibe sample is taken, precisely weighed, put in a 10 mL measuring flask, added with dimethyl sulfoxide to be dissolved and diluted to the scale, and the obtained solution is shaken evenly to serve as a test solution; 3 measuring, wherein 1 microliter of the reference substance solution and 1 microliter of the test solution are taken precisely and injected into a gas chromatograph, a chromatogram is recorded, the content is calculated through the external standard method, and the separation degrees between all peaks should meet the requirement.
Description
technical field [0001] The invention belongs to the field of analytical chemistry, in particular to a method for detecting residual solvents in ezetimibe. Background technique [0002] Residual solvents in pharmaceuticals refer to organic solvents used in the production of raw materials and preparations but not completely removed. If the residual amount of organic solvent exceeds the safe value, it will have a certain impact on the patient's body, so there are strict restrictions on residual solvents in medicines. In the guiding principles of the International Council for Harmonization of Technical Requirements for Registration of Drugs for Human Use, the solvents commonly used in drug production are divided into 4 categories according to the degree of hazard, and the limit value of each solvent is specified. According to the residual solvent content requirements stipulated in the 2010 edition of Chinese Pharmacopoeia, Appendix VIII P Residual Solvents Determination Method ...
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
Inventor 王庆鹏孙冬梅邢方姝杨永霞贾银芳刘志康
Owner LEPU PHARMACEUTICAL CO LTD