HPLC method for separating alvimopan and optical isomers thereof

Abstract

The invention discloses an HPLC method for separating alvimopan and optical isomers thereof. The method can effectively separate the alvimopan and the optical isomers thereof by using a chiral mobilephase method or a common modified silica gel filler chromatographic column, and the separation degree is high; a chiral mobile phase additive is N-dodecanoyl-L-proline, N-dodecanoyl-4-hydroxy-L-proline or N-acetyl-L-hydroxyproline, and a common modified silica gel filler is eugenol or a curcumin bonded modified silica gel.

Description

technical field [0001] The invention belongs to the field of analysis, and relates to the separation and detection of optical isomers in alvimopan raw materials. Background technique [0002] The chemical name of Alvimopan is [[(2S)-2-[[(3R,4R)-4-(3-hydroxyphenyl)-3,4-dimethylpiperidin-1-yl]methyl ]-3-Phenylpropionyl]amino]acetic acid, a highly selective and specific opioid receptor antagonist, is the first and only drug approved for the treatment of postoperative ileus in the world. The U.S. Food and Drug Administration (FDA) approved it for marketing in May 2008. It is suitable for accelerating the recovery of upper and lower gastrointestinal tract functions after primary resection and anastomosis of part of the large intestine or small intestine. In October 2013, the FDA changed its indication to "used to accelerate the recovery of the upper and lower gastrointestinal tract functions of patients after surgery, and partial intestinal primary resection and anastomosis are ...

AI Technical Summary

Problems solved by technology

[0004] Although the literature has reported HPLC methods for the determination of alvimopan optical isomer impurities, these methods either rely on chiral packing chromatographic columns, or rely on ovomucoid-bonded silica packing chromatographic columns, which are expensive

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