ABSTRACT
A selective and sensitive high performance liquid chromatography-electrospray ionization mass spectrometry method has been developed for the determination of tolterodine tartrate in human plasma. Tolterodine tartrate was extracted from plasma with n-hexane: isopropanol (95:5, v/v). The organic layer was evaporated and the residue was redissolved in mobile phase comprised of acetonitrile–water (10mM CH3COONH4, pH 3.0) = 55:45 (v/v). An aliquot of 10 µl was chromatographically analyzed on a prepacked ZORBAX XDB-ODS C18 column (2.1mm×30mm, 3.5 micron) particles by means of selected-ion monitoring (SIM) mode mass spectrometry. Standard curves were linear (r = 0.998) over the concentration range of 0.05–30.0 ng/ml and had good accuracy and precision. The limit of detection (LOD) was 0.02 ng/ml. The validated LC–ESI–MS method has been used successfully to study tolterodine tartrate pharmacokinetic, bioavailability and bioequivalence in 12 healthy male volunteers.
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