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
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  • Abstract
  • Description
  • Claims
  • Application Information

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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 impuri...

Method used

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  • 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

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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...

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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

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Application Information

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IPC IPC(8): G01N30/02
Inventor 鲍明梁尤猛赵新峰
Owner JINAN ORIENT KAIYUAN PHARMA TECH
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