Comparison of approaches for assessing detection and quantitation limits in bioanalytical methods using HPLC for sotalol in plasma.

ABSTRACT: The limit of detection (LOD) and limit of quantification (LOQ) stand elements in the validation of analytical and bioanalytical methods as emphasized in numerous guidelines. Despite this, the absence of a universal protocol for establishing these limits has led to varied approaches among researchers and analysts in literature. In this work we present the latest graphical strategy of validation known as the uncertainty profile to assess the LOQ and LOD. Then, we conducted a comparative study of this approach with those based on accuracy profile and parameters of the calibration curve. We realize the uncertainty profile from the uncertainty parameter calculated from the tolerance interval. Furthermore, we provide a succinct overview of alternative methods for computing these limits. This inc

SUBMITTER: Lambarki LZ 

PROVIDER: S-EPMC11829023 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature