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BUPROPION HYDROCHLORIDE: THE DEVELOPMENT OF A CHIRAL SEPARATION USING A CHIRAL AGP COLUMN

A chiral high-performance liquid chromatographic separation was developed for bupropion active ingredient. The mobile phase parameters that may influence the separation were studied and included: mobile phase pH, type and concentration of organic modifier, type and concentration of buffer, amount of analyte injected, and column temperature. The optimized chiral separation baseline resolved the two enantiomers in less than 10 minutes. Method validation was also performed for the separation. The method was found to be linear over a range of 0.5 μg/g to 99.8 μg/g with a correlation coefficient greater than 0.999. The limit of detection was determined to be 0.25 μg/g while the limit of quantitation was found to be 0.5 μg/g. Method precision was found to be 0.8% and 1.9% for the two enantiomers, while the system precision was found to be 0.4% and 0.5% for the two enantiomers.