The purpose of this investigation is to develop an undergraduate laboratory experiment that would address the question of whether or not a selected prescription drug contains exactly the same components and concentrations as its generic version. This study has practical implications in the healthcare industry, where generic drugs are substituted for more expensive brand-name drugs. Healthcare insurance companies claim generics are equivalent to brand-name drugs; however, critics note that there have been reports of formulation inconsistencies in generics obtained especially from sources outside the US. This investigation uses HPLC (high pressure liquid chromatography) to compare the name-brand prescription drug ProzacŪ to its generic equivalent fluoxetine hydrochloride. Comparison of the retention times, peak heights, and peak areas of the components of both ProzacŪ and fluoxetine hydrochloride, allows for an evaluation of equivalence. A separation methodology using HPLC is developed from published literature sources for use in the undergraduate laboratory.
Using a separation technique, the components of a brand-name drug and its generic are analyzed for equivalence.
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Back to The 37th Middle Atlantic Regional Meeting (May 22-25, 2005)