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A method for detecting related substances in ezetimibe rosuvastatin calcium tablets

A technology related to substances and detection methods, applied in the field of pharmaceutical analysis, to achieve the effects of high sensitivity, good accuracy, and simple mobile phase preparation

Active Publication Date: 2022-02-15
南京科默生物医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] The purpose of the present invention is to solve the problem of the lack of comprehensive impurity identification and separation of ezetimibe rosuvastatin calcium tablets in the prior art, and provide a simple and easy-to-operate method that can simultaneously detect multiple ezetimibe rosuvastatin calcium tablets Analytical method of related substances in calcium tablets

Method used

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  • A method for detecting related substances in ezetimibe rosuvastatin calcium tablets
  • A method for detecting related substances in ezetimibe rosuvastatin calcium tablets
  • A method for detecting related substances in ezetimibe rosuvastatin calcium tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038](1) Sample preparation: take 5 tablets of ezetimibe rosuvastatin calcium tablets, put them in a 50ml measuring bottle, add 12ml of water-acetonitrile-acetic acid (40:60:0.1), ultrasonicate for 30min, cool to room temperature, add water - Dilute acetonitrile-acetic acid (40:60:0.1) to the mark, centrifuge for 5 minutes (10000 rpm), take the supernatant, filter it with a 0.45 μm PP filter head, discard 1 ml of the filtrate, and obtain.

[0039] (2) Reference substance solution: take about 10mg of ezetimibe reference substance and about 10mg (specification: 10mg / 10mg) or 5mg (specification: 10mg / 5mg) of rosuvastatin calcium reference substance, weigh them accurately, and place in 100ml volume In the bottle, add water-acetonitrile-acetic acid (40:60:0.1) to dilute to the mark, and shake well. Precisely measure 1ml, put it in a 100ml measuring bottle, add water-acetonitrile-acetic acid (40:60:0.1) to dilute to the mark, and shake well.

[0040] (3) Brand model of high perfor...

Embodiment 2

[0051] (1) Sample preparation: take 5 tablets of ezetimibe rosuvastatin calcium tablets, put them in a 50ml measuring bottle, add 12ml of water-acetonitrile-acetic acid (40:60:0.1), ultrasonicate for 30min, cool to room temperature, add water - Dilute acetonitrile-acetic acid (40:60:0.1) to the mark, centrifuge for 5 minutes (10000 rpm), take the supernatant, filter it with a 0.45 μm PP filter head, discard 1 ml of the filtrate, and obtain.

[0052] (2) Reference substance solution: take about 10mg of ezetimibe reference substance and about 10mg (specification: 10mg / 10mg) or 5mg (specification: 10mg / 5mg) of rosuvastatin calcium reference substance, weigh them accurately, and place in 100ml volume In the bottle, add water-acetonitrile-acetic acid (40:60:0.1) to dilute to the mark, and shake well. Precisely measure 1ml, put it in a 100ml measuring bottle, add water-acetonitrile-acetic acid (40:60:0.1) to dilute to the mark, and shake well.

[0053] (3) Brand model of high perfo...

Embodiment 3

[0064] (1) Sample preparation: take 5 tablets of ezetimibe rosuvastatin calcium tablets, put them in a 50ml measuring bottle, add 12ml of water-acetonitrile-acetic acid (40:60:0.1), ultrasonicate for 30min, cool to room temperature, add water - Dilute acetonitrile-acetic acid (40:60:0.1) to the mark, centrifuge for 5 minutes (10000 rpm), take the supernatant, filter it with a 0.45 μm PP filter head, discard 1 ml of the filtrate, and obtain.

[0065] (2) Reference substance solution: take about 10mg of ezetimibe reference substance and about 10mg (specification: 10mg / 10mg) or 5mg (specification: 10mg / 5mg) of rosuvastatin calcium reference substance, weigh them accurately, and place in 100ml volume In the bottle, add water-acetonitrile-acetic acid (40:60:0.1) to dilute to the mark, and shake well. Precisely measure 1ml, put it in a 100ml measuring bottle, add water-acetonitrile-acetic acid (40:60:0.1) to dilute to the mark, and shake well.

[0066] (3) Brand model of high perfo...

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Abstract

The invention belongs to the technical field of drug analysis, and in particular relates to a method for detecting related substances in ezetimibe rosuvastatin calcium tablets. Using high performance liquid chromatography, HORIZON Aurashell C18, which uses silica gel co-bonded with octadecyl and pentafluorophenyl through core-shell technology, is used as a chromatographic column, and methanol-water-trifluoroacetic acid is used as the A mobile phase. The acetonitrile solution containing trifluoroacetic acid was used as mobile phase B, which was completed by gradient elution. The method disclosed by the invention can simultaneously detect 23 kinds of known impurities in ezetimibe rosuvastatin calcium tablets. detection efficiency. It provides a reliable impurity spectrum reference for the research on related substances of Ezetimi and Bresuvastatin Calcium Tablets. It can be used as the impurity assignment and detection of related substances in Ezetimi and Bresuvastatin Tablets. It has positive effects and practical applications value.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a method for detecting related substances in ezetimibe rosuvastatin calcium tablets by using high performance liquid chromatography. Background technique [0002] Ezetimibe is an oral, powerful lipid-lowering drug. Its mechanism of action is different from other lipid-lowering drugs. This product is attached to the brush border of the small intestinal villi, inhibiting the absorption of cholesterol, thereby reducing the cholesterol in the small intestine to the liver. Transport, which reduces the storage of cholesterol in the liver and increases the clearance of cholesterol from the blood. Its structure is as follows: [0003] [0004] Rosuvastatin calcium is a selective HMG-CoA reductase inhibitor. HMG-CoA reductase inhibitors are the rate-limiting enzymes that convert 3-hydroxy-3-methylglutaryl-CoA to mevalonate, the precursor of cholesterol. Rosuvastatin...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N30/86
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74G01N30/8631G01N2030/324
Inventor 苏梅叶玉廷薛佳琪陆慧月张孝清
Owner 南京科默生物医药有限公司
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