Method for separating glycopyrronium bromide enantiomers through capillary electrophoresis technique, and inspecting impurities of enantiomers

Abstract

The invention relates to a method for separating glycopyrronium bromide enantiomers through a capillary electrophoresis technique, and inspecting impurities of the enantiomers. The glycopyrronium bromide enantiomers are separated through capillary electrophoresis, the positions of the peaks of four glycopyrronium bromide enantiomer monomers are confirmed, and the limit of enantiomers in glycopyrronium bromide is calculated according to an impurity control technique; and water is used to prepare all tested samples, a capillary electrophoresis buffer solution is a sodium dihydrogen phosphate buffer solution, and sulfonated-beta-cyclodextrin (S-beta-C-D) is added to the above buffer salt. The method adopting the capillary electrophoresis technique to separate glycopyrronium bromide has the advantages of good separation effect, low amount of the samples, no pollution and low cost, and is suitable for separating racemic glycopyrronium bromide.

Description

technical field The invention belongs to the technical field of medicine, and relates to a capillary electrophoresis method for splitting four chiral enantiomers of a racemic drug muscarinic receptor antagonist glycopyrronium bromide and a research method for checking the enantiomer impurities. Background technique Glycopyrronium bromide (G1ycopyrronium Bromide) is a quaternary ammonium anticholinergic drug, its structure contains two chiral carbon atoms, and there are two pairs of enantiomers (RS, SS, SR, RR), that is, four chiral enantiomers The products that have been marketed at home and abroad are all mixtures of enantiomers, that is, racemic drugs, and their structures are shown in (I). (I) The separation of chiral enantiomers, especially chiral drugs, has become one of the important topics in the field of analytical chemistry in recent years, because the pharmacological effects of drugs are realized through strict chiral recognition and matching with macromolecul...

AI Technical Summary

Problems solved by technology

At present, the commonly used method for the separation of chiral drugs is chiral high performance liquid chromatography. By adding a chiral selective agent to the mobile phase or using a chiral chromatographic column for separation and inspection, the former often has poor separation effect and specificity. It is not strong, the latter column is more expensive, and the cost is higher. Usually, several types of chiral liquid chromatography columns are required to meet a specific analysis requirement. It takes a long time to find a column suitable for the resolution of glycopyrronium bromide. Large consumption, narrow application range and other disadvantages; gas chromatography is used for the inspection of chiral drug enantiomers, requiring samples to have certain volatility and thermal stability, and the application is very limited

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