Development and validation of a bioanalytical assay for the measurement of total and unbound teicoplanin in human serum.

ABSTRACT:

Background

The glycopeptide teicoplanin is considered first-line treatment for severe infections caused by Gram-positive bacteria. Individualized treatment of teicoplanin is gaining interest. As only protein-unbound drug is pharmacologically active, a sensitive assay measuring unbound and total teicoplanin is indispensable for pharmacological research and dose optimization.

Objectives

To develop and validate a UPLC-MS/MS method to quantify unbound and total teicoplanin in human serum.

Methods

The developed assay was validated according to the ICH guideline M10 on Bioanalytical Method Validation and study sample analysis. Unbound teicoplanin was obtained by ultrafiltration. The assay was cross-validated with a quantitative microsphere (QMS) immunoassay in a side-by-sid

SUBMITTER: Mouton JWA 

PROVIDER: S-EPMC10631822 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature