Detection method of afatinib and isomer of afatinib

A volume ratio, n-hexane technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of difficult separation and detection of enantiomer impurities

Active Publication Date: 2015-03-04
SUNSHINE LAKE PHARM CO LTD
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Problems solved by technology

[0004] There is a chiral carbon in the structure of afatinib, which has an enantiomer impurity. During the detection of afatinib, it is difficult to separate and detect afatinib and its enantiomer impurity.

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  • Detection method of afatinib and isomer of afatinib
  • Detection method of afatinib and isomer of afatinib
  • Detection method of afatinib and isomer of afatinib

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Embodiment Construction

[0009] The inventor has developed a method for separating and detecting afatinib and its enantiomer impurities through research. The method includes: carrying out on a high-performance liquid chromatograph, and the chromatographic column is CHIRALPAK OZ-H, 250mm×4.6mm, 5μm chiral chromatographic column; the mobile phase is a mixed solution of n-hexane, ethanol, methanol and diethylamine, and in the mixed solvent, the volume ratio of methanol and diethylamine is 100:0.1, and n-hexane, ethanol, methanol and diethylamine The volume ratio of amine is 550-650:350-250:100:0.1; the column temperature is 15°C-35°C; the flow rate is 0.5mL / min-1.0mL / min.

[0010] The inventor tried to use CHIRALPAK AS-H, 4.6mmX250mm, 5μm chiral chromatographic column; IC, 4.6mmX250mm, 5μm, chiral column; OD-H, 4.6mmX250mm, 5μm chiral chromatography column; OJ-H, 4.6mmX250mm, 5μm chiral chromatographic column, etc. are analytical chromatographic columns; the same mobile phase is used for the analysi...

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Abstract

The invention relates to a liquid phase separation detection method of afatinib and enantiomer of the afatinib, and belongs to the technical field of separation detection. The method comprises the step of carrying out isocratic elution by adopting 250mm*4.6mm and 5 micrometers CHIRALPAK OZ-H chiral chromatographic column as a separation chromatographic column and adopting a mixed solution of n-hexane, ethanol, methanol and diethylamine as a flow phase. By adopting the method, the afatinib and an enantiomer impurity of the afatinib can be effectively separated and detected, and the peak pattern of a chromatographic peak is good.

Description

technical field [0001] The invention relates to an HPLC separation and detection method for afatinib and its isomer impurities, belonging to the technical field of pharmacy. Background technique [0002] Afatinib, the chemical name is (2E)-4-[(3-chloro-4-fluorophenyl)amino]-6-{[4-(N,N-dimethylamino)-1 -Oxo-2-buten-1-yl]amino}-7-((3S)-tetrahydrofuran-3-yloxy)-quinazoline; is epidermal growth factor receptor (EGFR) and human epidermal growth factor An irreversible inhibitor of receptor 2 (HER2) tyrosine kinase, its dimaleate has been approved for the treatment of diseases such as advanced non-small cell lung cancer (NSCLC), and the structure of afatinib is shown in formula (1) : [0003] [0004] There is a chiral carbon in the structure of afatinib, which has an enantiomer impurity. During the detection of afatinib, it is difficult to separate and detect afatinib and its enantiomer impurity. Contents of the invention Summary of the invention [0005] The invention p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
Inventor 杨丽珍罗勇峰杨凤智
Owner SUNSHINE LAKE PHARM CO LTD
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