Looking for breakthrough ideas for innovation challenges? Try Patsnap Eureka!

Related substance detection method for trelagliptin succinate and preparation thereof

A technique for detecting troxagliptin succinate and its detection method, which is applied in the field of detection of related substances of troxagliptin succinate and its preparations, can solve problems such as difficult separation, and achieve high accuracy and sensitivity, strong specificity, and adaptability strong effect

Active Publication Date: 2014-12-24
JINAN ORIENT KAIYUAN PHARMA TECH
View PDF2 Cites 17 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] There are no reports on the detection methods of related substances of trexagliptin succinate and its preparations. The difficulty of the detection method lies in the fact that various by-product impurities, dimer impurities, and isomer impurities may be produced during its synthesis. etc., the impurities that cannot be removed after refining are similar to the chromatographic behavior of the main drug, and it is not easy to completely separate them

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Related substance detection method for trelagliptin succinate and preparation thereof
  • Related substance detection method for trelagliptin succinate and preparation thereof
  • Related substance detection method for trelagliptin succinate and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Detection method for related substances of trexagliptin succinate

[0034] Experimental equipment and chromatographic conditions:

[0035] Shimadzu high-performance liquid chromatography, Agilent C18 chromatographic column (5μm, 150×4.6mm), with phosphate buffer (take 7.8g of sodium dihydrogen phosphate, 5mL of triethylamine, add water to dissolve and dilute to 1000mL, phosphoric acid to adjust pH to 5.0) as mobile phase A, acetonitrile as mobile phase B, gradient elution was performed, the detection wavelength was 278nm; the flow rate was 0.8-1.2ml / min; the injection volume was 5-200μl. .

[0036] Reagent:

[0037] Acetonitrile (HPLC grade) was from ACS Company of the United States, and ultrapure water was made by an ultrapure water machine.

[0038] Choice of Chromatographic Conditions

[0039] 1.1 mobile phase

[0040] We compared the relevant detection methods of alogliptin benzoate, a similar drug of trexagliptin succinate, through experiments:

[0041] [Insp...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

No PUM Login to View More

Abstract

The invention provides a related substance detection method for trelagliptin succinate and preparation thereof. According to the related substance detection method for trelagliptin succinate and preparation thereof, a diode array detector is adopted, a chromatographic column adopted in the method is an octadecyl silane bonded silica gel chromatographic column, a mobile phase A is phosphate buffer solution, a mobile phase B is acetonitrile, the volume ratio of the phosphate buffer solution to acetonitrile is 60: 40 to 85: 15, the pH value of the phosphate buffer solution is 5.0 to 5.5, the concentration of the phosphate buffer solution is 0.05 to 0.1mol / L, and a detection wavelength is 278nm. The various ingredients in the analysed substances are thorough in separation and high in operability; the analysis method is high in specificity, high in accuracy and sensitivity, high in adaptability, and capable of providing a basis for the safety, effectiveness and controllability of medicines.

Description

technical field [0001] The invention relates to a detection method of dipeptidyl peptidase-4 inhibitor crude drug and preparation, in particular to a detection method of related substances of trexagliptin succinate and preparation thereof. Background technique [0002] Trelagliptin succinate, its chemical name is: 2-[6-(3-amino-piperidin-1-yl)-3-methyl-2,4-dioxo-3,4 -Dihydro-2H-pyrimidin-1-ylmethyl]-4-fluoro-benzonitrile, succinate [0003] Its structural formula is: [0004] [0005] Trelagliptin is a once-weekly dipeptidyl peptidase IV (DPP-4) inhibitor that controls blood glucose levels through selective and sustained inhibition of DPP-4. DPP-4 is an enzyme that triggers the inactivation of incretins, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), two incretins in the Plays an important role in blood sugar regulation. Inhibition of DPP-4 can increase blood glucose level-dependent insulin secretion, thereby controlling blood ...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
IPC IPC(8): G01N30/02
Inventor 鲍明梁尤猛赵新峰
Owner JINAN ORIENT KAIYUAN PHARMA TECH
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Patsnap Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Patsnap Eureka Blog
Learn More
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic, Popular Technical Reports.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap|About US| Contact US: help@patsnap.com