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High performance liquid chromatography-electrospray ionization mass spectrometric determination of tolterodine tartrate in human plasma.

Author(s): Zhang B, Zhang Z, Tian Y, Xu F

Affiliation(s): Center for Instrumental Analysis, China Pharmaceutical University, Nanjing, Jiangsu 210009, PR China.

Publication date & source: 2005-09-25, J Chromatogr B Analyt Technol Biomed Life Sci., 824(1-2):92-8.

Publication type: Clinical Trial; Randomized Controlled Trial

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. With oxybutynin as internal standard, 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 (10 mM CH3COONH4, pH 3.0)=50:50 (v/v). An aliquot of 10 microl was chromatographically analyzed on a prepacked Shimadzu Shim-pack VP-ODS C18 column (150 mmx2.0 mm I.D.) by means of selected-ion monitoring (SIM) mode mass spectrometry. Standard curves were linear (r=0.9993) over the concentration range of 0.1-30.0 ng/ml and had good accuracy and precision. The within- and between-batch precisions were within 10% relative standard deviation. The limit of detection (LOD) was 0.05 ng/ml. The validated LC-ESI-MS method has been used successfully to study tolterodine tartrate pharmacokinetic, bioavailability and bioequivalence in 20 healthy male volunteers.

Page last updated: 2006-01-31

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