Determination of talinolol in human plasma by high performance liquid chromatography-electrospray ionization mass spectrometry: Application to pharmacokinetic study

A rapid and sensitive method for determination and screening in human plasma of talinolol is described using propranolol as the internal standard. The analytes in plasma were extracted by liquid-liquid extraction using methyl t-butyl ether. After removed and dried the upper organic phase, the extracts were reconstituted with a fixed volume of buffer of ammonium acetate and acetonitrile (60:40, v/v). The extracts were analyzed by a HPLC coupled to electrospray ionization mass spectrometry (HPLC-MS/ESI). The HPLC separation of the analytes was performed on a Phenomenex C 18 (250 mm x 4.6 mm, 5 mu m, USA) column, with a flow rate of 0.85 mL/mm. The complete elution was obtained within 5.5 min. The calibration curve was linear in the 1.0-400.0 ng/mL range for talinolol, with a coefficient of determination of 0.9996. The average extraction recovery was above 83%. The methodology recovery was between 101% and 102%. The limit of detection (LOD) was 0.3 ng/mL for talinolol. The intraday and inter-day coefficients of variation were less than 6%. This HPLC-MS/ESI procedure was used to assess the pharmacokinetics of talinolol. A single oral 50 mg dose of talinolol tablet was administered to 12 healthy Chinese volunteers, the main pharmacokinetic data are as follows: Cm, was 147.8 +/- 63.8 ng/mL; t(max) was 2.0 +/- 0.7 h; t(1/2) was 12.0 +/- 2.6 h. The method is accurate, sensitive and simple for the pharmacokinetic study of talinolol. (c) 2007 Elsevier B.V. All rights reserved.