Separation detection method of apremilast and apremilast enantiomer

An enantiomer and detection method technology, applied in the field of separation and detection of apremilast and its enantiomers, can solve the problems of unpredictable separation effect, failure to meet the minimum resolution requirements, etc., and achieve accuracy High, specific effects
CN104792913AActive Publication Date: 2015-07-22SUZHOU YABAO PHARMA R&D CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
SUZHOU YABAO PHARMA R&D CO LTD
Publication Date
2015-07-22

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Abstract

The invention discloses a high-efficient liquid phase chromatograph separation detection method of apremilast and apremilast enantiomer. A chromatographic condition is to adopt a direct-chain starch chiral column, and an n-hexane-low alcohol solution is adopted as a flow phase to carry out the separation determination for apremilast and apremilast enantiomer. By adopting the high-efficient liquid phase chromatograph separation detection method of the apremilast and apremilast enantiomer, the apremilast enantiomer can be effectively separated and determined, the specificity is high, the accuracy is high, and the method can be used for effectively controlling the quality of apremilast active ingredients.
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Description

technical field

[0001] The invention relates to the field of pharmaceutical analytical chemistry, in particular to a separation and detection method for apremilast and its enantiomers. Background technique

[0002] Apremilast is a phosphodiesterase inhibitor. It is the first small-molecule drug approved by the FDA on March 21, 2014 for the treatment of arthritis caused by psoriasis. The original research company is Celgene. The chemical structural formula is as follows:

[0003]

[0004] Separation of enantiomers containing chiral carbon atoms has always been a difficult point in quality control during the synthesis and preparation of chiral drugs. Apremilast is a chiral drug. In order to ensure the safety of the drug, it is necessary to detect the content of enantiomer impurities in the drug in the quality standard. Enantiomers cannot be separated by conventional high-performance liquid chromatography and must be separated using a suitable chiral column.

[0005] Chin...

Claims

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