Application of a semi-automated 96-well format solid-phase extraction, column-switching, fluorescence detection protocol for the determination of alendronate in human urine samples obtained from a bioequivalence study

被引：22

作者：

Apostolou, Constantinos ^{[1
]}

Dotsikas, Yannis ^{[1
]}

Kousoulos, Constantinos ^{[1
]}

Tsatsou, Georgia ^{[1
]}

Colocouri, Filomila ^{[1
]}

Soumelas, Georgios-Stefanos ^{[1
]}

Loukas, Yannis L. ^{[1
]}

机构：

[1] Univ Athens, Sch Pharm, Dept Pharmaceut Chem, Lab Pharmaceut Anal & Bioequivalence Serv GLP Com, GR-15771 Athens, Greece

来源：

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS | 2007年 / 43卷 / 03期

关键词：

alendronate; bioequivalence; column-switching; 96-well format; urine;

D O I：

10.1016/j.jpba.2006.09.012

中图分类号：

O65 [分析化学];

学科分类号：

070302 ; 081704 ;

摘要：

In the current study, a semi-automated, 96-well format, solid-phase extraction (SPE), analytical column - switching method for alendronate determination in human urine is developed, validated and applied to a bioequivalence study. The current protocol was a substantial improvement of an existing classical method. A robotic liquid handling system was employed to simplify and reduce the time of sample preparation procedure. Automated SPE was carried out using a 96-well cartridge plate and a vacuum control system. Urine samples were determined by applying a column-switching protocol with fluorescence detection. Analysis time, due to the column-switching procedure, was about half of the conventional LC approach (11.5 min instead of 21 min). The method application required the determination of alendronate in urine samples obtained from 96 healthy volunteers as part of a bioequivalence study of two 70 mg alendronate sodium tablets. All major pharmacolcinetic parameters of the bioequivalence study were estimated and reported. (c) 2006 Elsevier B.V. All rights reserved.

引用

页码：1151 / 1155

页数：5

共 19 条

[1] Spectroscopic and HPLC methods for the determination of alendronate in tablets and urine [J].