High performance liquid chromatographic assay and drug dissolution studiesof fluoxetine hydrochloride in capsule formulations

A sensitive and simple high performance liquid chromatographic method for t he assay of fluoxetine HCl was developed. The procedure is based on the use of the reversed-phase high performance liquid chromatographic method with UV detector. Each analysis required no longer than 6 minutes. The detector response was linear in the range of 0.01-50 mu g/mL for fluoxetine HCl. The detection limit was found to be 0.0057 mu g/mL. There was no significant d ifference between interday and intraday studies for fluoxetine HCl determin ed for two different concentrations. This method was applied, without any i nterferences from the excipients, for the determination of the drug in caps ules and in drug dissolution studies. This method can be useful in routine quality control analysis of fluoxetine HCl pharmaceutical dosage form.