A chiral high-performance liquid chromatographic separation was developed f
or bupropion active ingredient. The mobile phase parameters that may influe
nce the separation were studied and included: mobile phase pH, type and con
centration 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 fou
nd to be linear over a range of 0.5 mug/g to 99.8 mug/g with a correlation
coefficient greater than 0.999. The limit of detection was determined to be
0.25 mug/g while the limit of quantitation was found to be 0.5 mug/g.
Method precision was found to be 0.8% and 1.9% for the two enantiomers, whi
le the system precision was found to be 0.4% and 0.5% for the two enantiome