A method for determining related substances in trexagliptin succinate raw material

A technology of troxagliptin succinate and related substances, which is applied in the field of determination of related substances in trexagliptin raw materials, can solve problems such as impurity cannot be covered, quality control of this product cannot be guaranteed, applicability cannot be judged, and the quality can be achieved. control effect
CN105699547BActive Publication Date: 2017-03-29中山万远新药研发有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
中山万远新药研发有限公司
Publication Date
2017-03-29

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Abstract

The invention discloses a method for measuring related substances in succinic acid Trelagliptin raw materials and relates to the field of analytic chemistry. According to the method, high performance liquid chromatography is adopted, a sample solution is injected into a high performance liquid chromatograph, and the related substances in the succinic acid Trelagliptin raw materials are measured; according to chromatographic conditions, a 100-5C18 chromatographic column of the Kromasil company is adopted as a chromatographic column, a flowing phase A and a flowing phase B are both a mixed solution of an acid aqueous solution and an organic solvent, the sum of the volume percentage of the flowing phase A and the volume percentage of the flowing phase B is kept 100% all the time, and linear gradient elution is performed. According to the method, the 100-5C18 chromatographic column of the Kromasil company is adopted, the gradient elution program of the flowing phases is optimized, and the related substances in the succinic acid Trelagliptin raw materials can be effectively separated. The method solves the separation and measurement problem of the related substances in the succinic acid Trelagliptin raw materials, and therefore it is guaranteed that the mass of the succinic acid Trelagliptin raw materials is controllable.
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Description

technical field

[0001] The invention relates to the field of analytical chemistry, in particular to a method for determining related substances in trexagliptin raw materials. Background technique

[0002] Among the antidiabetic drugs, the research of orally administered small molecule DPP-IV inhibitors is the most active. DPP-IV is an enzyme in the body that triggers the inactivation of incretins, glucone-like peptide-1 and glucose-dependent insulinotropic polypeptide, two incretins that play an important role in blood glucose regulation . Inhibition of DPP-IV can increase blood glucose level-dependent insulin secretion, thereby controlling blood glucose levels.

[0003] DPP-IV inhibitor drugs are named "gliptins". There are 17 such drugs. Among them, trexagliptin was developed by Takeda Pharmaceutical and was first approved for marketing in Japan in 2014. It is an ultra-long-acting The DPP-IV inhibitor only needs to be taken orally once a week, which can produce continuo...

Claims

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