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Detection method of aminopyridine isomer

The technology of an aminopyridine and a detection method, which is applied in the detection field of aminopyridine isomers, can solve problems such as lack of a good detection method, and achieve the effects of accurate and reliable detection results and strong specificity.

Inactive Publication Date: 2016-09-28
合肥远志医药科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

S-(R)-3-tert-butoxycarbonylaminopiperidine is commonly used in the preparation of raw materials in the early stage, but it has many isomers, and there is no good detection method at present

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0022] Adopt high-performance liquid chromatography to carry out, and the step comprises:

[0023] (1) Prepare a linagliptin starting material sample solution, which includes a test solution; and a reference solution;

[0024] (2) Inject the sample solution obtained in step (1) into a high-performance liquid chromatograph, use the mobile phase as the mobile phase for gradient elution, and record the chromatogram;

[0025] Wherein, the preparation method of the test solution comprises the following steps: accurately weigh the starting material of linagliptin, add diluent to dissolve and dilute to a concentration of linagliptin of 10mg / ml, and obtain the test solution ;

[0026] The chromatographic column stationary phase of described high-performance liquid chromatography uses amylose-three (3,5-xylyl carbamate) as filler;

[0027] Mobile phase: n-heptane-isopropanol-diethylamine (90:10:0.05).

[0028] Chromatographic conditions:

[0029] Chromatographic column: Chiralpak A...

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PUM

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Abstract

The invention discloses a detection method of an aminopyridine isomer. The method is implemented by adopting a high performance liquid chromatography. The method comprises the following steps that 1, a starting material sample solution is prepared; 2, the sample solution obtained in the step 1 is injected into a high performance liquid chromatograph, a flowing phase is adopted for isocratic elution, and a chromatogram map is recorded, wherein amylose-tris(3,5-dimethylphenylcarbamate) is used as a filling agent according to a chromatographic column fixing phase of the high performance liquid chromatography, and n-heptane-isopropanol-diethylamine (90:10:0.05) is adopted as the flowing phase. The detection method detects starting material isomers under the same liquid phase condition and is strong in specificity, and detection results are accurate and dependable.

Description

technical field [0001] The invention relates to the technical field of drug detection, in particular to a method for detecting aminopyridine isomers. Background technique [0002] Linagliptin (Linagliptin Tablets), Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, can improve type 2 diabetes mellitus (T2DM) adult patients on the basis of diet control and physical exercise levels of blood sugar control. S-(R)-3-tert-butoxycarbonylaminopiperidine is commonly used in the preparation of raw materials in the early stage, but it has many isomers, and there is no good detection method at present. Contents of the invention [0003] The technical problem to be solved by the present invention is to overcome the defects of the prior art and provide a method for detecting aminopyridine isomers. [0004] In order to solve the above-mentioned technical problems, the present invention provides the following technical scheme: a method for detecting aminopyridine isomers, which ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 岳娟丁青竹刘斐
Owner 合肥远志医药科技开发有限公司