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A kind of related substance detection method of trexagliptin succinate and preparation thereof

The technology of a trelagliptin succinate and a detection method is applied in the detection field of the related substances of the trelagliptin succinate and its preparations, which can solve the problems of difficult separation and the like, achieve high accuracy and sensitivity, good system applicability, Actionable effect

Active Publication Date: 2016-07-20
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 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

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  • A kind of related substance detection method of trexagliptin succinate and preparation thereof
  • A kind of related substance detection method of trexagliptin succinate and preparation thereof
  • A kind of related substance detection method of trexagliptin 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, AgilentC18 chromatographic column (5 μm, 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 the pH to 5.0) is the mobile phase A, acetonitrile is the mobile phase B, and the gradient elution is performed, the detection wavelength is 278nm; the flow rate is 0.8-1.2ml / min; the injection volume is 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 experiment...

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Abstract

The invention provides a method for detecting related substances of troxagliptin succinate and its preparation. A diode array detector is used. The chromatographic column used in the method is an octadecylsilane-bonded silica gel chromatographic column, and the mobile phase A is phosphate Buffer, the mobile phase B is acetonitrile, and the volume ratio of the phosphate buffer to acetonitrile is 60:40 to 85:15, the pH of the phosphate buffer is 5.0 to 5.5, and the concentration of the phosphate buffer is 0.05~0.1mol / L, the detection wavelength is 278nm. The components in the analyte are completely separated, and the operability is strong. The analysis method has strong specificity, high accuracy and sensitivity, and strong adaptability, which provides the basis for ensuring the safety, effectiveness and controllability of drugs.

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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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
Inventor 鲍明梁尤猛赵新峰
Owner JINAN ORIENT KAIYUAN PHARMA TECH
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