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Determination of solifenacin succinate, a novel muscarinic receptor antagonist, and its major metabolite in rat plasma by semi-micro high performance liquid chromatography.

Yanagihara T, Aoki T, Soeishi Y, Iwatsubo T, Kamimura H

Drug Metabolism Research Laboratories, Astellas Pharma Inc., 1-8, Azusawa 1-chome, Itabashi-ku, Tokyo 174-8511, Japan. takamitsu.yanagihara@jp.astellas.com

A sensitive and specific method for the simultaneous determination of the unchanged drug (solifenacin) and its major metabolite (M1, 4S-hydroxy solifenacin) in rat plasma was developed and validated. Both solifenacin and M1 were extracted from rat plasma by a two-step liquid-liquid extraction and analyzed by semi-micro HPLC with UV detection at an absorbance wavelength of 220 nm. The chromatographic separations were performed on a TSKgel ODS-80Ts (5 microm, 150 mmx2.0 mm i.d.) reversed-phase column with a mobile phase of 0.1 M phosphate buffer (pH 3.0):acetonitrile (71:29, v/v). The intra-day precision (expressed as coefficient of variation, CV) ranged from 0.4% to 1.7%, and the accuracy (expressed as relative error, RE) ranged from -5.2% to 2.0% for solifenacin. The corresponding precision ranged from 1.3% to 3.2%, and accuracy ranged from -4.0% to 8.6% for M1. The lower limit of quantitation for both solifenacin and M1 was 2 ng/ml when 1 ml of plasma was used. No endogenous interference was observed in rat plasma.

Published 12 November 2007 in J Chromatogr B Analyt Technol Biomed Life Sci, 859(2): 241-5.
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