A High-Performance Liquid Chromatographic Method for the Quantitative Enantioselective Analysis of Mefloquine Stereoisomers

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Abstract
A rapid quantitative, enantioselective HPLC method for the analysis of the four stereoisomers, (+) and (-) erythro and (+) and (-) threo forms, of mefloquine has been developed using a Chiralpak AD analytical column containing amylose tris-3,5-dimethylphenyl carbonate coated on silica gel and hexane/ethanol/diethylamine (96: 4:0.1, v/v%) as the mobile phase. This method made it possible to quantitate small amounts of threo form in the presence of the erythro form of mefloquine, the form which is used as the active ingredient in commercial mefloquine tablets. Tablets from three sources were studied to estimate their optical purity, and it was found that tablets from one source contain 0.27 w/w% of the (-)-threo and 0.25 w/w% of the ( + )-threo form, tablets from the second source contain 0.056 and 0.042 w/w% (-)- and ( + )-threo, respectively, and tablets from the third source contain 0.052 w/w% ( + )-threo, with the remainder erythro.