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Data Validation

Data Validation

Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:

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Updated: Nov 20, 2025

A General Method for Detecting Nitrosamide Formation in the In Vitro Metabolism of Nitrosamines by Cytochrome P450s

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Optimisation and validation of a sensitive bioanalytical method for niclosamide.

Usman Arshad, Henry Pertinez, Helen Box

Biorxiv : the Preprint Server for Biology

|January 20, 2021

Summary

A new bioanalytical assay for niclosamide (a potential SARS-CoV-2 antiviral) was developed. This sensitive liquid chromatography tandem mass spectrometry method enables accurate pharmacokinetic studies for drug repurposing.

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Published on: January 27, 2014

Area of Science:

Pharmacology
Analytical Chemistry
Infectious Diseases

Background:

The SARS-CoV-2 pandemic necessitates rapid development of effective treatments.
Drug repurposing offers a faster route to therapeutic interventions compared to novel drug discovery.
Niclosamide, an anthelmintic drug, shows potent in vitro antiviral activity against SARS-CoV-2, making it a candidate for repurposing.

Approach:

Developed and validated a sensitive liquid chromatography tandem mass spectrometry (LC-MS/MS) assay for niclosamide quantification.
The assay demonstrated high accuracy and precision across two distinct dynamic ranges (0.78–100 ng/mL and 31.25–2000 ng/mL).
Established reliable bioanalytical methods crucial for pharmacokinetic investigations.

Key Points:

The validated LC-MS/MS assay provides a sensitive and reproducible method for measuring niclosamide concentrations.
The assay exhibits a wide dynamic range, suitable for various preclinical and potentially clinical applications.
Accurate pharmacokinetic data is essential for understanding niclosamide's efficacy and safety in SARS-CoV-2 treatment.

Conclusions:

The presented bioanalytical assay is a critical tool for the preclinical evaluation of niclosamide's exposure-response relationship against SARS-CoV-2.
This assay can facilitate further investigation into niclosamide repurposing for COVID-19 treatment.
Adaptation of the assay for clinical trials will be vital for assessing niclosamide's therapeutic potential in human subjects.