View More View Less
  • 1 Department of Medicinal and Pharmaceutical Chemistry, Faculty of Pharmacy and Medical Sciences, Amman University, P.O. Box 263, Amman, 19328, Jordan
  • | 2 Department of Biopharmaceutics and Clinical Pharmacy, Faculty of Pharmacy, Jordan University, Amman, Jordan
  • | 3 Jordan Company for Pharmaceutical Research, P.O. Box 950435, Amman, 11195, Jordan, tawfiqarafat@yahoo.com
Restricted access

Summary

A sensitive and specific high-performance liquid chromatographic-electrospray ionization tandem mass spectrometric (HPLC-ESI-MS-MS) method for quantification of tamsulosin in human plasma, using propranolol as internal standard (IS), has been developed, validated successfully, then used in a clinical study. Plasma (0.5 mL) was mixed with 50 μL 1 m sodium carbonate solution. Tamsulosin and propranolol were isolated from the mixture by liquid-liquid extraction with 7:3 (v/v) hexane-ethyl acetate. Reversed-phase chromatography was performed on a C8 column at 25°C with 70:30:0.1 (v/v) methanol-water-formic acid as mobile phase at a flow-rate of 1.0 mL min−1. Quantification was achieved in positive-ion mode by monitoring the product ions at m/z 409.1 → 270.9, 228.0, and 200.0 (tamsulosin) and m/z 260.1 → 183.0 (IS). The lowest limit of quantification was 0.25 ng mL−1, and the calibration range was 0.25–50 ng mL−1. Within and between batch precision (expressed as coefficient of variation, CV) did not exceed 10.8% and accuracy was within 5.0% deviation of the nominal concentration. Recovery of tamsulosin from plasma was >83.0%. The validated method was used for clinical study of tamsulosin in human volunteers.

  • [1]. M.I. Wilde D. McTavish 1996 Drugs 52 883.

  • [2]. M. Lee 2000 Ann. Pharmacother. 34 188.

  • [3]. C.J. Dunn A. Matheson D.M. Faude 2002 Drugs Aging 19 135.

  • [4]. C. Chapple K.E. Anderson 2002 World J. Urol. 19 397.

  • [5]. Product monograph, Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT 06877, USA, February 13, 2007.

  • [6]. S. Yamada M. Suzuki C. Tanaka R. Mori R. Kimura O. Inagaki K. Honda M. Asano T. Takenaka K. Kawabe 1994 Clin. Exp. Pharmacol. Physiol. 21 405.

    • Search Google Scholar
    • Export Citation
  • [7]. K. Honda N. Nomose C. Nakagawa 1987 J. Pharm. Pharmacol. 39 316.

  • [8]. Y. Soeishi M. Kobori S.I. Kobayashi S. Higuchi 1990 J. Chromatogr. B 533 291.

  • [9]. J. Macek J. Klima P. Ptáček 2004 J. Chromatogr. B 809 307.

  • [10]. H. Matsushima K.I. Takanuki H. Kamimura T. Watanabe S. Higuchi 1997 J. Chromatogr. B 695 317.

  • [11]. L. Ding L. Li P. Tao J. Yang Z. Zheng 2002 J. Chromatogr. B 767 75.

  • [12]. M. Qi P. Wang L. Liu 2004 J. Chromatogr. B 805 7.

  • [13]. N.V. Ramakrishna K.N. Vishwottam S. Manoj M. Koteshwara S. Wishu D.P. Varma 2005 Biomed. Chromatogr. 19 709.

  • [14]. P.K. Rahkonen O. Pärssinen E. Leppänen T. Mauriala M. Lehtonen S. Auriola 2007 J. Pharm. Biomed. Anal. 43 606.

  • [15]. S. Agarwal K.V. Gowda A.K. Sarkar D. Ghosh U. Bhaumik T.K. Chattaraj T.K. Pal 2008 Chromatographia 67 893.

  • [16]. R. Willoughby E. Sheehan S. Mitrovich 2002 A Global View of LC-MS 2nd edn Global View Publishing Pittsburgh, PA.

  • [17]. M.C. Michel C. Korstanje W. Krauwinkel M. Kuipers 2005 Eur. Urol. Suppl. 4 15.

  • [18]. US Department of HealthHuman Services 2001 Food and Drug Administration, Guidance for Industry: Bioanalytical Method Validation Centre for Drug Evaluation and Research Rockville, MD.

    • Search Google Scholar
    • Export Citation
  • [19]. B.K. Matuszewski M.L. Constanzer C.M. Chavez-Eng 2003 Anal. Chem. 75 3019.

  • [20]. K.V. Gowda U. Mandal P.S. Selvan S. Solomon A. Ghosh A.K. Sarkar S. Agarwal T.N. Rao T.K. Pal 2007 J. Chromatogr. 558 13.

  • [21]. A. Van Eeckhaut , K. Lanckmans, S. Sarre, J. Smolders, and Y. Michotte, J. Chromatogr. B (2009), doi:10.1016/j.jchromb. 2009.01.003 (article in press).

    • Search Google Scholar
    • Export Citation
All Time Past Year Past 30 Days
Abstract Views 43 43 1
Full Text Views 9 4 0
PDF Downloads 5 1 0