Quantitation of a new potent angiotensin II receptor antagonist,TCV-116, and its metabolites in human serum and urine |
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| Institution: | 1. Sechenov First Moscow State Medical University, Moscow, Russia;2. Scientific Center for Expertise of Medical Products, Institute of Clinical Pharmacology, Moscow, Russia;3. AstraZeneca R&D, Mölndal, Sweden;4. World Health Organization (WHO), Geneva, Switzerland;5. Johannes Gutenberg-University, Mainz, Germany;6. University of Maryland, Baltimore, Maryland;7. International Pharmaceutical Federation (FIP), The Hague, The Netherlands;8. RIVM—National Institute for Public Health and the Environment, Bilthoven, The Netherlands;9. Institute of Pharmaceutical Technology, Goethe University, Frankfurt am Main, Germany |
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| Abstract: | A sensitive high-performance liquid chromatographic (HPLC) method is described for the determination of a new potent antihypertensive agent, TCV-116, and its two metabolites (M-I and M-II) in human serum or urine. After pre-treatment of the specimens, the analytes were determined using a column switching technique, except for the metabolites in urine which were determined by gradient elution mode HPLC. The quantitation limits for TCV-116, M-I and M-II were all 0.5 ng/ml in serum, and 0.5, 10 and 10 ng/ml in urine, respectively. The methods were applied to clinical trials of TCV-116. |
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