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Method for detecting dissolution rate of clopidogrel hydrogen sulfate tablets by using HPLC

A technology of clopidogrel bisulfate tablets and clopidogrel bisulfate, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of unstable absorbance of blank medium, inability to accurately measure dissolution rate, etc., and achieve good specificity, The effect of improving solubility

Inactive Publication Date: 2019-11-26
ZHENGZHOU TAIFENG PHARMA CO LTD
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Problems solved by technology

In the 2015 edition of the Chinese Pharmacopoeia, ultraviolet spectrophotometry is used for determination, but in the process of consistency evaluation, the dissolution medium with a pH of 4.5 configured according to the method of the Chinese Pharmacopoeia, when measured at 240nm by the ultraviolet spectrophotometric method in the Pharmacopoeia, the blank medium The absorbance has been unstable, resulting in the inability to accurately determine the dissolution rate of each sampling point

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  • Method for detecting dissolution rate of clopidogrel hydrogen sulfate tablets by using HPLC
  • Method for detecting dissolution rate of clopidogrel hydrogen sulfate tablets by using HPLC
  • Method for detecting dissolution rate of clopidogrel hydrogen sulfate tablets by using HPLC

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Embodiment Construction

[0021] The technical solution of the present invention will be further described below in conjunction with specific examples, and a series of verifications of the method of the present invention will be done at the same time.

[0022] 1 Instruments and reagents

[0023] Thermo U3000 high performance liquid chromatograph;

[0024] Agilent dissolution apparatus (Agilent);

[0025] Clopidogrel bisulfate tablets (specification 75mg / tablet, batch number 20170923);

[0026] Clopidogrel bisulfate standard substance (purchased from the Central Inspection Institute, content 99.5%);

[0027] Methanol and acetonitrile were chromatographically pure (Merk).

[0028] 2 HPLC method to determine the dissolution rate of clopidogrel bisulfate tablets

[0029] Detection chromatographic conditions for dissolution determination: chromatographic column is ovomucin-bonded silica gel chiral chromatography column ULTRONES-OVM; mobile phase is 0.01mol / L potassium dihydrogen phosphate solution: acet...

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Abstract

The invention provides a method for detecting the dissolution rate of clopidogrel hydrogen sulfate tablets by using HPLC. The method comprises the following steps: preparing a standard solution; drawing a standard curve; making preparation of a clopidogrel hydrogen sulfate tablet test solution; measuring the test solution; calculating the concentration of clopidogrel hydrogen sulfate in the test solution by a peak area and a standard curve; and then calculating a dissolution rate of the clopidogrel hydrogen sulfate tablet. The used dissolution media are acetate buffer solutions that contain 0.1 to 0.3% of Tween 80 and have the pH values of 4.5. According to the provided method, a problem of unstable absorbance of the blank medium is solved. Since the dissolution media contain the Tween 80,usage of an organic solvent is avoided and the solubility of clopidogrel hydrogen sulfate is increased; after a serious of verification of the method, the provided method has advantages of high specificity, accurate result, and high stability; and the dissolution rate of the clopidogrel hydrogen sulfate tablet in the dissolution medium with the pH of 4.5 can be measured accurately.

Description

technical field [0001] The invention relates to the technical field of dissolution rate determination of clopidogrel hydrogen sulfate tablets, in particular to a method for detecting the dissolution rate of clopidogrel hydrogen sulfate tablets by using HPLC. Background technique [0002] Clopidogrel bisulfate tablets are a platelet aggregation inhibitor developed by Sanofi, France, which was first approved by the FDA in 1997. The main component of clopidogrel bisulfate tablets is clopidogrel bisulfate, which can selectively inhibit the binding of ADP to platelet receptors, and then inhibit the activation of ADP and glycoprotein GPⅡb / Ⅲa complexes, thereby inhibiting the aggregation of platelets, mainly It is used for the prevention and treatment of heart, brain and other arterial circulation disorders caused by high platelet aggregation. In the 2015 edition of the Chinese Pharmacopoeia, ultraviolet spectrophotometry is used for determination, but in the process of consistenc...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N2030/047
Inventor 沙薇张兴爽马宗普朱盼盼
Owner ZHENGZHOU TAIFENG PHARMA CO LTD
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