Abstract
Abstract Liquid chromatographic (LC) methods were developed for assay of fluoxetine hydrochloride, its meta isomer, and 12 related compounds in drug raw materials. The method for assay and determination of the meta isomer requires an Exsil ODS-B column; a mobile phase consisting of tetrahydrofuran, acetonitrile, and buffer; a flow rate of 1 mL/min; and detection at 214 nm. The method for related compounds specifies a Spherisorb nitrile column; a mobile phase consisting of tetrahydrofuran, acetonitrile, and buffer; a flow rate of 1 mL/min; and detection at 214 nm. The limits of quantitation in the presence of the drug are 0.1% for the meta isomer and 0.05% or less for the related compounds. Assay precision was less than 1.0% on triplicate weighings. Drug contents of 4 raw material samples were between 98.8 and 100.1%. Impurity levels in the 4 samples ranged from 0.14 to 0.45%. In addition, one sample contained ca 0.13% of the meta isomer. A second analyst, using columns from different suppliers, obtained similar results.
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