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A simple and rapid high‐performance liquid chromatography method for determination of alendronate sodium in beagle dog plasma with application to preclinical pharmacokinetic study
Author(s) -
Meng Jian,
Meng Qiang,
Zheng Liangyuan
Publication year - 2010
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.1266
Subject(s) - beagle , chromatography , chemistry , pharmacokinetics , derivatization , high performance liquid chromatography , protein precipitation , detection limit , pharmacology , medicine
A simple and rapid high performance liquid chromatographic (HPLC) method for quantifying alendronate in beagle dog plasma was developed, validated and applied to a pharmacokinetic study. The sample preparation involved coprecipitation with CaCl 2 and derivatization with o ‐phthalaldehyde. Chromatographic separation was achieved on a Diamonsil™ C 18 (250 × 4.6 mm, 5 µm) using acetonitrile–0.4% EDTA‐Na 2 (16:84, v/v) containing 0.034% of NaOH as mobile phase. The fluorimetric detector was operated at 339 nm (excitation) and 447 nm (emission). The linearity over the concentration range of 5.00–600 ng/mL for alendronate was obtained and the lower limit of quantification was 5.00 ng/mL. For each level of quality control samples, inter‐day and intra‐day precisions were less than 8.52 and 7.42% and accuracies were less than 9.07%. The assay was applied to the analysis of samples from a pharmacokinetic study. Following the oral administration of 70 mg alendronate sodium to beagle dogs, the maximum plasma concentration ( C max ) and elimination half‐life were 152 ± 27.3 and 1.75 ± 0.267 h, respectively. The method was demonstrated to be highly feasible and reproducible for pharmacokinetic studies. Copyright © 2009 John Wiley & Sons, Ltd.