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Ibrutinib and test method of isomer of ibrutinib

A volume ratio, alkane solvent technology, applied in the field of ibrutinib and its isomer impurities, high-performance liquid phase separation and detection, can solve the problems of difficult separation and detection of enantiomer impurities

Active Publication Date: 2015-03-11
RUYUAN HEC PHARM
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Problems solved by technology

[0004] There is a chiral carbon in the structure of ibrutinib, which has an enantiomer impurity. In the process of detecting ibrutinib, it is difficult to separate and detect ibrutinib and its enantiomer impurity

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Embodiment Construction

[0009] Through research, the inventor has developed a method for separating and detecting ibrutinib and its enantiomer impurities. By using specific chromatographic columns and controlling other detection conditions, it is possible to effectively separate ibrutinib and its opposite Enantiomer impurities.

[0010] A method for separating and detecting ibrutinib, comprising: detecting on a high performance liquid chromatograph, the chromatographic column is AD-H, 4.6mm X 250mm, 5μm, chiral chromatographic column; mobile phase is a mixed solvent of alkane solvent and alcohol solvent, the volume ratio of alkane solvent to alcohol solvent is 35:65; column temperature is 25°C-40°C; The flow rate is 0.3mL / min-0.9mL / min.

[0011] The inventors tried to use IC, 4.6mm X 250mm, 5μm, chiral chromatography column, CHIRALPAK AS-H, 4.6mm X 250mm, 5μm chiral chromatography column, OD-H, 4.6mm X 250mm, 5μm, chiral chromatography column, OJ-H, 4.6mm X 250mm, 5μm, chiral chromatographic ...

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Abstract

The invention relates to ibrutinib and a liquid-phase separation test method of a corresponding isomer impurity of ibrutinib and belongs to the technical field of separation testing. The test method comprises the steps of taking a CHIRALPAK AD-H, 4.6mm*250mm, 5-micrometer chiral chromatographic column as a separation chromatographic column, and taking a mixed solvent of an alkene solvent and an alcohol solvent at a volume ratio of 35:65 as a mobile phase. The method can effectively separate and test ibrutinib and the corresponding isomer impurity of ibrutinib, and be used for production, and a separation degree can reach above 5.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a high-efficiency liquid phase separation detection method for ibrutinib and its isomer impurities. Background technique [0002] Ibrutinib, chemical name 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidine -1-yl]-1-piperidinyl]-2-propen-1-one, its structure is shown in formula (1); it is a kind of irreversible Bruton's tyrosine kinase (BTK, Bruton's tyrosine kinase) Inhibitors can inhibit the proliferation and survival of malignant B cells, and can be used to treat diseases such as chronic lymphocytic leukemia (CLL) and small cell lymphocytic lymphoma: [0003] [0004] There is a chiral carbon in the structure of ibrutinib, which has an enantiomer impurity. In the process of detecting ibrutinib, it is difficult to separate and detect ibrutinib and its enantiomer impurity. Contents of the invention Summary of the invention [0005] The inven...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 蓝英姚博杨凤智肖毅
Owner RUYUAN HEC PHARM
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