Method for detecting tofacitinib chiral intermediates and enantiomer thereof

A technology of chiral intermediates and enantiomers, which is applied in the field of analytical chemistry, can solve problems such as the lack of methods for detecting optical isomers and the inability to effectively separate compounds, and achieve stable and reliable results, high sensitivity and resolution , good repeatability and durability
CN112697906AActive Publication Date: 2021-04-23SHANGHAI SCIENPHARM CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
SHANGHAI SCIENPHARM CO LTD
Publication Date
2021-04-23

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Abstract

The invention belongs to the field of analytical chemistry, and particularly relates to a citric acid tofacitinib citrate chiral intermediate and an enantiomer thereof. A chromatographic column taking amylase tri(3,5-dimethyl phenyl carbamate) coated porous silica gel microspheres as a filler is adopted. A mixed solution of n-hexane-isopropanol-methanol-diethylamine- trifluoroacetic acid is used as a mobile phase for isocratic elution, and the solution enters a detector for detection. The citric acid tofacitinib citrate chiral intermediate and the enantiomer thereof can be effectively separated, and the method has the advantages of high sensitivity and separation degree, good repeatability and durability, simplicity in operation, and stable and reliable result. The method has extremely important significance in realizing the citric acid tofacitinib citrate chiral intermediate and tofacitinib citrate quality control.
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Description

technical field

[0001] The invention belongs to the field of analytical chemistry, and in particular relates to a method for detecting a chiral intermediate of tofacitinib and its enantiomer. Background technique

[0002] Tofacitinib citrate is an oral anti-rheumatoid arthritis inhibitor developed by Pfizer (Pfrizer), the main mechanism is JAK-1 and -3 tyrosine kinase inhibitors, its chemical name is 3- ((3R,4R)-4-methyl-3-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)piperidin-1-yl)-3-oxopropane Nitrile citrate (1:1), the English name is Tofacitinib Citrate, tofacitinib citrate was approved by the US Food and Drug Administration (FDA) on November 6, 2012, and it was launched in March 2013 On the 25th, it was approved for marketing by the Japan Pharmaceuticals and Medical Devices Agency (PMDA), and on March 22, 2017, it was approved by the European Medicines Quality Agency (EDQM).

[0003] The molecule of tofacitinib citrate contains 2 chiral carbon atoms, and there are fo...

Claims

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