High performance liquid chromatography method for simultaneous determination of linagliptin and metformin contents

A technology of high performance liquid chromatography and metformin, which is applied in the field of simultaneous determination of linagliptin and metformin, and can solve the problems that there are no literature reports on content analysis methods

Inactive Publication Date: 2016-01-27
JIANGSU SINOBIOPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] There is no literature report on the simul

Method used

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  • High performance liquid chromatography method for simultaneous determination of linagliptin and metformin contents
  • High performance liquid chromatography method for simultaneous determination of linagliptin and metformin contents
  • High performance liquid chromatography method for simultaneous determination of linagliptin and metformin contents

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Embodiment 1

[0021] A high-performance liquid chromatography method for simultaneously determining the content of linagliptin and metformin. The chromatographic conditions are as follows: octylsilane-bonded silica gel is used as the filler, the detection wavelength is 225nm, the column temperature is 35°C, and the flow rate is 0.8ml / min; Reversed-phase high-performance liquid chromatography is adopted, and the mobile phase is a buffered salt solution and a polar organic solvent added with an ion-pairing reagent. The buffered salt solution added with an ion-pairing reagent is phase A, and the polar organic solvent is phase B. In the mobile phase, A The ion-pair reagent of the phase is sodium heptanesulfonate, and the buffer salt is potassium dihydrogen phosphate; the organic solvent of phase B in the mobile phase is acetonitrile.

[0022] The addition amount of the ion-pair reagent sodium heptanesulfonate added in phase A is 10mmol / L, and the pH value of the buffered saline solution added wi...

Embodiment 2

[0030] A high-performance liquid chromatography method for simultaneously determining the content of linagliptin and metformin. The chromatographic conditions are as follows: octylsilane-bonded silica gel is used as the filler, the detection wavelength is 230nm, the column temperature is 45°C, and the flow rate is 1.2ml / min; Reversed-phase high-performance liquid chromatography is adopted, and the mobile phase is a buffered salt solution and a polar organic solvent added with an ion-pairing reagent. The buffered salt solution added with an ion-pairing reagent is phase A, and the polar organic solvent is phase B. In the mobile phase, A The ion-pair reagent of the phase is sodium heptanesulfonate, and the buffer salt is potassium dihydrogen phosphate; the organic solvent of phase B in the mobile phase is acetonitrile.

[0031] The addition amount of the ion-pairing reagent sodium heptanesulfonate added in the A phase is 30mmol / L, and the pH value of the buffered salt solution add...

Embodiment 3

[0039] A high-performance liquid chromatography method for simultaneously determining the content of linagliptin and metformin. The chromatographic conditions are as follows: octylsilane-bonded silica gel is used as the filler, the detection wavelength is 227nm, the column temperature is 40°C, and the flow rate is 1.0ml / min; Reversed-phase high-performance liquid chromatography is adopted, and the mobile phase is a buffered salt solution and a polar organic solvent added with an ion-pairing reagent. The buffered salt solution added with an ion-pairing reagent is phase A, and the polar organic solvent is phase B. In the mobile phase, A The ion-pair reagent of the phase is sodium heptanesulfonate, and the buffer salt is potassium dihydrogen phosphate; the organic solvent of phase B in the mobile phase is acetonitrile.

[0040] The addition amount of the ion-pair reagent sodium heptanesulfonate added in phase A is 20mmol / L, and the pH value of the buffered salt solution added with...

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Abstract

The present invention discloses a high performance liquid chromatography method for simultaneous determination of linagliptin and metformin contents, a reverse-phase high performance liquid chromatography method is used, a to-be-tested solution and a contrast solution are prepared, 10mul of the to-be-tested solution and 10mul of the contrast solution are respectively taken by measuring, and injected into a chromatographic instrument, chromatogram is recorded, and determination of linagliptin and metformin contents can be completed by peak area calculation and conversion into dry content by external standard method; the advantages of the method are that: the method fills the blank of no analysis method for determination of linagliptin and metformin contents in the prior art, can satisfy the needs of research and development and production, and provides the necessary technical support for linagliptin drug to come into the market early.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a method for simultaneously determining linagliptin and metformin [0002] High performance liquid chromatography for guanidine content. Background technique [0003] Linagliptin, English name linagliptin, chemical name 8-[(3R)-3-amino-1-piperidinyl]-7-(2-butynyl)-3,7-dihydro-3-methyl Base-1-[(4-methyl-2-quinazolinyl)methyl]-1H-purine-2,6-dione. Linagliptin is a new type of dipeptidyl peptidase inhibitor withdrawn from Boehringer Ingelheim and Eli Lilly for the treatment of type 2 diabetes. Linagliptin monotherapy was launched in my country in April 2013; The English name is Metforminhydrochloride, and the chemical name is 1,1-dimethylbiguanide hydrochloride. Metformin hydrochloride tablets have been used clinically for more than 50 years. As one of the most widely used hypoglycemic drugs, it is used to control diabetes and its complications. [0004] In patents CN102596191 and CN10339...

Claims

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Application Information

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IPC IPC(8): G01N30/88
Inventor 黄乐群罗晶
Owner JIANGSU SINOBIOPHARMA
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