کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
1224764 967931 2006 5 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
High-performance liquid chromatography method for determining alendronate sodium in human plasma by detecting fluorescence: Application to a pharmacokinetic study in humans
موضوعات مرتبط
مهندسی و علوم پایه شیمی شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
High-performance liquid chromatography method for determining alendronate sodium in human plasma by detecting fluorescence: Application to a pharmacokinetic study in humans
چکیده انگلیسی

A high-performance liquid chromatographic (HPLC) method was developed using diethylamine (DEA) solid-phase extraction (SPE), 9-fluorenylmethyl derivative (FMOC) and fluorescence detection for quantifying alendronate in human plasma. Sample preparation involved a manual protein precipitation with trichloroacetic acid, a manual coprecipitation of the bisphosphonate with calcium phosphate and derivatization with 9-fluorenylmethyl chloroformate in citrate buffer at pH 11.9. Liquid chromatography was performed on a Capcell Pak C18 column (4.6 mm × 150 mm, 5 μm particles), using a gradient method starting with mobile phase acetonitrile/methanol-citrate/pyrophosphate buffer (32:68, v/v). The total run time was 25 min. The fluorometric detector was operated at 260 nm (excitation) and 310 nm (emission). Pamidronate was used as the internal standard. The limit of quantification was 1 ng/ml using 3 ml of plasma. The intra- and inter-day precision expressed as the relative standard deviation was less than 15%. The assay was applied to the analysis of samples from a pharmacokinetic study. Following the oral administration of 70 mg of alendronate sodium to volunteers, the maximum plasma concentration (Cmax) and elimination half-life were 40.94 ± 19.60 ng/ml and 1.67 ± 0.50 h, respectively. The method was demonstrated to be highly feasible and reproducible for pharmacokinetic studies including bioequivalence test of alendronate sodium in humans.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 40, Issue 1, 23 January 2006, Pages 168–172
نویسندگان
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