High performance liquid chromatography-electrospray ionization mass spectrometric determination of tolterodine tartrate in human plasma.
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.
Zhang
Beibei
B
Center for Instrumental Analysis, China Pharmaceutical University, Nanjing, Jiangsu 210009, PR China.
Zhang
Zunjian
Z
Tian
Yuan
Y
Xu
Fengguo
F
D000284:Administration, Oral; D019540:Area Under Curve; D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D003408:Cresols / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D006801:Humans; D008297:Male; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D010665:Phenylpropanolamine / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods*; D000068737:Tolterodine Tartrate
D001559:Benzhydryl Compounds; D003408:Cresols; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate