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Analysis method for determining releasing rate of quetiapine fumarate sustained release tablet

A technology for analyzing quetiapine fumarate and an analysis method, which is applied in the analysis field of determining the release rate of quetiapine fumarate sustained-release tablets, can solve problems such as failure to achieve basic release and drug inability to be released, and achieve stable retention time and peak good shape effect

Inactive Publication Date: 2019-08-16
NOVAST LABORATORIES (CHINA) LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Under this method, the basic release is not achieved. This is because the developed formulation contains 50% high-viscosity hydroxypropyl cellulose, which will swell under this condition and the drug cannot be released.

Method used

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  • Analysis method for determining releasing rate of quetiapine fumarate sustained release tablet
  • Analysis method for determining releasing rate of quetiapine fumarate sustained release tablet
  • Analysis method for determining releasing rate of quetiapine fumarate sustained release tablet

Examples

Experimental program
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Effect test

Embodiment 1

[0026] Determination of the release rate of quetiapine fumarate sustained-release tablets (specification: 200mg, batch number: 19RD425001, containing 50% hyprolose K4M):

[0027] (1) Instruments and conditions:

[0028] Dissolution Apparatus: Agilent Dissolution Apparatus, USP Method 1, Blue Method;

[0029] Dissolution medium: pH6.8 buffer salt containing 1.0% sodium lauryl sulfate solution;

[0030] Medium volume: 500ml;

[0031] Speed: 100rpm;

[0032] Temperature: 37°C±0.5°C;

[0033] Sampling mode: automatic sampling;

[0034] Sampling volume: 10ml;

[0035] Sampling times: 1, 2, 4, 6, 9, 12, 16, 20 and 24 hours.

[0036] (2), experimental steps:

[0037] Take 6 tablets of this product, weigh and record the weight of each tablet, put them into each dissolution vessel respectively, and operate according to the law, respectively, at 1, 2, 4, 6, 9, 12, 16, 20 and 24 hours, from each dissolution vessel Remove the dissolution solution from the medium, filter the disso...

Embodiment 2

[0051] Determination of the release rate of quetiapine fumarate sustained-release tablets (specification: 200 mg, batch number: 19RD425002, containing 50% hyprolose K15M):

[0052] (1) Instruments and conditions:

[0053] Dissolution Apparatus: Agilent Dissolution Apparatus, USP Method 1, Blue Method;

[0054]Dissolution medium: pH6.8 buffer salt containing 1.0% sodium lauryl sulfate solution;

[0055] Medium volume: 500ml;

[0056] Speed: 100rpm;

[0057] Temperature: 37°C±0.5°C;

[0058] Sampling mode: automatic sampling;

[0059] Sampling volume: 10ml;

[0060] Sampling times: 1, 2, 4, 6, 9, 12, 16, 20 and 24 hours.

[0061] (2), experimental steps:

[0062] Take 6 tablets of this product, weigh and record the weight of each tablet, put them into each dissolution vessel respectively, and operate according to the law, respectively, at 1, 2, 4, 6, 9, 12, 16, 20 and 24 hours, from each dissolution vessel Remove the dissolution solution from the medium, filter the diss...

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Abstract

The invention discloses an analysis method for determining releasing rate of a quetiapine fumarate sustained release tablet. The method is about determining releasing rate of the quetiapine fumarate sustained release tablet, dissolution medium in the releasing rate method is composed of water, buffer salt and surfactant, and a liquid chromatography is used for analyzing a sample for test. The dissolution medium in the determining method can improve releasing quantity of the quetiapine fumarate sustained release tablet in a releasing rate experiment, build a proper chromatographic condition andachieve an aim of analysis.

Description

technical field [0001] The invention specifically relates to an analysis method for measuring the release rate of quetiapine fumarate sustained-release tablets. Background technique [0002] Quetiapine Fumarate Extended Release Tablets is a neurological drug indicated for the treatment of the features and symptoms of idiopathic Parkinson's disease. There is no chapter about quetiapine fumarate sustained-release tablets in the Chinese Pharmacopoeia. The release of quetiapine fumarate sustained-release tablets in the US Pharmacopoeia is based on 900ml of pH4.8 buffer solution as the dissolution medium after 4 hours of testing , and then converted to 1000ml of pH6.6 buffer solution, using the first method of the United States Pharmacopoeia <711> basket method for determination. The quetiapine fumarate sustained-release tablets (200 mg) developed by us through the bioequivalence pre-test were tested according to the above release method. Under the release conditions, the ...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/027
Inventor 王海霞钱云房敏戴娇玉顾稳耿思琪陈佳琪陈昌凤
Owner NOVAST LABORATORIES (CHINA) LTD
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