Determination of alendronate in low volumes of plasma by column-switching high-performance liquid chromatography method and its application to pharmacokinetic studies in human plasma

A sensitive and simple column-switching high-performance liquid chromatographic (HPLC) method with fluorescence detection was developed for the determination of alendronate in human plasma. Alendronate and pamidronate (internal standard, IS) in plasma including Na 2 EDTA were precipitated with sodiu...

Full description

Saved in:
Bibliographic Details
Published in:Archives of pharmacal research 2011, 34(12), , pp.2079-2086
Main Authors: Ban, Eunmi, Park, Ji-Youn, Kim, Hyung Tae, Kim, Chong-Kook
Format: Article
Language:English
Subjects:
Alendronate - blood
Alendronate - pharmacokinetics
Chemistry, Pharmaceutical - methods
Chemistry, Pharmaceutical - standards
Chromatography, High Pressure Liquid - methods
Chromatography, High Pressure Liquid - standards
Humans
Medicine
Pharmacology/Toxicology
Pharmacy
Reproducibility of Results
약학
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:A sensitive and simple column-switching high-performance liquid chromatographic (HPLC) method with fluorescence detection was developed for the determination of alendronate in human plasma. Alendronate and pamidronate (internal standard, IS) in plasma including Na 2 EDTA were precipitated with sodium hydroxide and calcium chloride after deproteinization using 10% trichloroacetic acid solution. The precipitated alendronate and IS were reconstituted by sodium citrate and citric acid and then derivatized with 9-fluorenylmethyl chloroformate. The resulting solution was injected onto an HPLC system consisting of a pretreatment column and an analytical column, which were connected with a six-port switching valve. The assay was linear in the concentration range of 2–100 ng/mL in 1 mL of plasma with high precision and accuracy, and the limit of detection was 0.5 ng/mL. It was successfully applied to evaluate the pharmacokinetic parameters of alendronate in human volunteers following single oral administration. The mean value of maximum alendronate plasma concentration (C max ) was 37.69 ng/mL, and the mean time to reach the C max (T max ) was 1.08 h. The area under the plasma concentration-time curve (AUC) and elimination half-life (T 1/2 ) were 106.48 ng/mL/h and 1.66 h, respectively.
ISSN:0253-6269
1976-3786
DOI:10.1007/s12272-011-1211-z