Separation of fudosteine on an achiral C₁₈column by HPLC with chiral ligand-exchange selectors as mobile phase additives

Abstract

A reversed-phase chiral liquid chromatographic method had been developed and validated for resolution of the enantiomers of racemic fudosteine. The effects on the separation of the amounts of anhydrous cupric sulfate and L-phenylalanine, the methanol content, mobile phase pH, and temperature were investigated. The method was validated for linearity, repeatability, intermediate precision, sample recovery, solution stability, and limits of detection (LOD). L-Phenylalanine and anhydrous cupric sulfate as chiral ligand-exchange complexes were used for separation, isomer identification, related substance investigation, and analysis of fudosteine enantiomers in fudosteine bulk drugs and fudosteine tablets.

Separation of Tryptophan Enantiomers by Ligand‐Exchange Chromatography With Novel Chiral Ionic Liquids Ligand

“…Four kinds of synthesized CILs all have enantioselectivities for tryptophan enantiomers. Taking resolution and retention time into consideration, [L-Pro] [CF 3 COO] was chosen to be the model selector to optimize the separation procedure. Under the optimal separation conditions, good enantioseparation was achieved with a resolution of 1.89.…”

“…Administration of highly pure chiral drugs is a major objective of the pharmaceutical industry to protect the public against damage caused by high drug concentrations or toxic side effects. Therefore, the development of methods for enantioseparation has attracted great interest in the past decades …”

“…Therefore, the development of methods for enantioseparation has attracted great interest in the past decades. [3][4][5] Currently, methods that have proved effective for the separation of enantiomers are mainly focused on highperformance liquid chromatography (HPLC), gas chromatography (GC), capillary electrophoresis (CE), and thin-layer chromatography (TLC) techniques. In addition, fluorescence, nuclear magnetic resonance, and mass spectroscopy are also used in the chiral discrimination and analysis.…”

Enantioseparation of basic drugs by reverse phase high‐performance liquid chromatography system using carboxymethyl‐β‐cyclodextrin as chiral mobile phase additive

“…11,12 On the other hand, the method of utilizing the CMPA has been widely used in exploratory research as a versatile and flexible method to demonstrate greater potential in chiral separation. 13,14 So far, a wide range of chiral selectors, including cyclodextrins (CDs), [14][15][16][17][18] chiral ion-pair inclusions, 19,20 and chiral ligand-exchange inclusions, [21][22][23] have been explored in CMPA techniques.…”