Method for detecting dissolution rate of alogliptin benzoate tablets by using liquid chromatography

A technology of alogliptin tablet and detection method, applied in the field of medicine and chemical industry, can solve the problems of long detection time, complex composition and the like

Inactive Publication Date: 2015-04-29
SUNSHINE LAKE PHARM CO LTD
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  • Abstract
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Problems solved by technology

The mobile phase of this method has adopted reagents such as ion-pair reagent sodium hexanesulfonate, potassium dihydrogen phosphate and potassium hydroxide, and the composition is complex; this method also adopts gradient elution, and the detection time is too long, so it is not suitable for rapid determination of albinobenzoic acid Dissolution of Gliptin Tablets

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  • Method for detecting dissolution rate of alogliptin benzoate tablets by using liquid chromatography
  • Method for detecting dissolution rate of alogliptin benzoate tablets by using liquid chromatography
  • Method for detecting dissolution rate of alogliptin benzoate tablets by using liquid chromatography

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Embodiment Construction

[0021] A kind of alogliptin benzoate tablet dissolution detection method provided by the invention is characterized in that:

[0022] The method is carried out on a high performance liquid chromatograph;

[0023] The chromatographic column is Welch Ultimate AQ-C18, 4.6×150mm, 5μm;

[0024] The mobile phase is a mixed solution of potassium dihydrogen phosphate aqueous solution and acetonitrile, wherein the pH value of the potassium dihydrogen phosphate aqueous solution is about 5.5-6.5, and the volume ratio of the potassium dihydrogen phosphate aqueous solution and acetonitrile is about 70:30-80:20.

[0025] Wherein, the detector can be a UV detector, and the detection wavelength is 278nm; the flow rate can be 0.2-2.0ml / min; the injection volume is 5-100μL; the column temperature is room temperature; and the running time can be about 5-10min.

[0026] In some embodiments, the potassium dihydrogen phosphate aqueous solution of the present invention has a concentration of about ...

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Abstract

The invention provides a method for detecting dissolution rate of alogliptin benzoate tablets. The method comprises the following steps: by adopting a Welch Ultimate AQ-C18 5-micron chromatographic column of 4.6*150mm, taking a mixed solution of phosphate aqueous solution with the pH value of 5.5-6.5 and acetonitrile as a mobile phase, performing isocratic elution, and detecting the dissolution rate of the alogliptin benzoate tablets on the liquid chromatography system. The detection method provided by the invention is economic, rapid and high-efficiency, has high specificity and is suitable for detecting the dissolution rate of the alogliptin benzoate tablets under different dissolution medium conditions.

Description

technical field [0001] The invention belongs to the field of medicine and chemical industry, and more specifically relates to a method for detecting the dissolution rate of alogliptin benzoate tablets by liquid chromatography. Background technique [0002] Alogliptin Benzoate, chemical name 2-(6-((3R)-3-aminopiperidin-1-yl)-3-methyl-2,4-dioxo-3,4-dihydropyrimidine -1 (2H) base) methyl) benzonitrile monobenzoate, structural formula: [0003] [0004] Chemical formula: C 18 h 21 N 5 o 2 ·C 7 h 6 o 2 Molecular weight: 461.5 [0005] It is a serine protease dipeptidyl peptidase IV (DPP-IV) inhibitor, which can maintain the levels of glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) in the body, and promote the secretion of insulin. So as to exert the hypoglycemic effect. The use of alogliptin benzoate for treating type 2 diabetes has been well known by the public, and its effect in treating type 2 diabetes is good. At present, t...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 王辉周芳妮范丽霞郝秋爽宋学志黄芳芳李倩霞
Owner SUNSHINE LAKE PHARM CO LTD
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