Determination method of R-succinic acid trelagliptin optical purity

A technology of troxagliptin succinate and optical purity, applied in the field of determination of optical purity of troxagliptin succinate, capable of solving the problems of low separation efficiency

Inactive Publication Date: 2017-03-22
DISHA PHARMA GRP +1
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Problems solved by technology

[0008] Purpose of the present invention: In order to solve the problem of low separation efficiency, we have developed a method for measuring the optical purity of R-trexagliptin succinate by chiral chromatography using a mobile phase that adds diethylamine

Method used

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  • Determination method of R-succinic acid trelagliptin optical purity
  • Determination method of R-succinic acid trelagliptin optical purity
  • Determination method of R-succinic acid trelagliptin optical purity

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Embodiment 1

[0047] The determination of the optical purity of embodiment 1 R-succinate trexagliptin sample

[0048] Instruments and reagents: high-performance liquid chromatography (Hitachi, Japan; Thermo Fisher Scientific Co., Ltd.); AD-H chiral chromatography column (250mm×4.6mm, 5μm; Daicel Pharmaceutical Chiral Technology Co., Ltd.); constant temperature Water bath (Jiangsu Jintan Kexing Instrument Factory); BT-25S electronic balance (Switzerland, Mettler). DL-1000D ultrasonic instrument (Shanghai Zhixin Instrument Co., Ltd.).

[0049] n-Hexane (chromatographically pure, Tianjin Biaoshiqi Technology Co., Ltd.); absolute ethanol (chromatographically pure, Tianjin Biaoshiqi Technology Co., Ltd.); diethylamine (analytical grade, Tianjin Guangcheng Chemical Reagent Co., Ltd.); R -Trexagliptin succinate reference substance (purity ≧99.9%, Disa Pharmaceutical Group Pharmaceutical Research Institute); S-succinate troxagliptin reference substance (purity ≧99.0%, Disha Pharmaceutical Group Ph...

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Abstract

The invention relates to a dipeptidyl peptidase-IV(DPP-IV) inhibitor and a detection method of the R-succinic acid trelagliptin optical purity. The invention relates to a method for determining the R-succinic acid trelagliptin optical purity by adopting chiral chromatography added with a mobile phase of diethylamine. According to the method, by adding diethylamine in the mobile phase, adjusting the mobile phase pH, stabilizing spatial configuration of asymmetric filling and modifying the bonding effect of the asymmetric filling on R-succinic acid trelagliptin and S-succinic acid trelagliptin, the separation efficiency between the R-succinic acid trelagliptin and S-succinic acid trelagliptin is improved, determination of the optical purity through chiral chromatography is achieved, and the technical problem of R-succinic acid trelagliptin optical purity determination is solved innovatively for the first time.

Description

technical field [0001] The invention relates to a method for detecting the optical purity of a dipeptidyl peptidase-IV (DPP-IV) inhibitor, that is, R-tragliptin succinate. Background technique [0002] Trelagliptin Succinate is a dipeptidyl peptidase-IV (DPP-IV) inhibitor, its chemical name is 2-[[6-[(3R)-3-amino-1-piperidin [Pyridyl]-3,4-dihydro-3-methyl-2,4-dioxo-1(2H)-pyrimidinyl]methyl]-4-fluorobenzonitrile succinate. Its main ingredient is trexagliptin. There is a chiral center in the structure of the compound, but the real pharmacological effect is the R configuration, and its structural formula is shown in formula 1: [0003] [0004] Formula 1: Structural formula of trexagliptin succinate [0005] Trexagliptin succinate is a dipeptidyl peptidase-IV (DPP-IV) inhibitor developed by Japan's Takeda Pharmaceutical Co., Ltd., which controls blood sugar levels by selectively and persistently inhibiting DPP-IV. Incretin (GLP-I) and glucose-dependent insulinotropic pol...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/74G01N30/06G01N30/86
CPCG01N30/74G01N30/06G01N30/8637
Inventor 张曼玉盛飞
Owner DISHA PHARMA GRP
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