Determination and validation of tiaprofenic acid in human plasma: A detailed LC-MS/MS-based analysis following ICH M10 guidelines and the accuracy profile approach

Bouchafra, H.; Orche, A.; Khabbaz, C.; Cheikh, A.; Karbane, M.; Faouzi, M.; Cherrah, Y.; Zarayby, L.; Hirri, A.

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Current Chemistry Letters

ISSN 1927-730x (Online) - ISSN 1927-7296 (Print) Quarterly Publication Volume 13 Issue 4 pp. 707-716 , 2024

Determination and validation of tiaprofenic acid in human plasma: A detailed LC-MS/MS-based analysis following ICH M10 guidelines and the accuracy profile approach Pages 707-716 Download PDF

Authors: Houda Bouchafra, Aimen El Orche, Choukri El Khabbaz, Amine Cheikh, Miloud El Karbane, My El Abbes Faouzi, Yahia Cherrah, Lhoussaine Zarayby, Aziz Hirri

DOI: 10.5267/j.ccl.2024.4.003

Keywords:

Abstract: The validation of bioanalytical methods holds critical importance for regulatory agencies and organizations dedicated to ensuring the safety, efficacy, and quality of pharmaceuticals. In this context, the recent release of the ICH M10 guideline in May 2022 represents a significant milestone in standardizing bioanalytical method validation globally. However, this guideline lacks explicit experimental protocols for implementation. In this study, we address the practical implementation of the newly released ICH M10 guideline by providing a detailed validation protocol for a bioanalytical method. Our method specifically targets tiaprofenic acid, a widely used nonsteroidal anti-inflammatory drug. Tiaprofenic acid is a critical component in bioequivalence studies, underscoring the necessity for precise and accurate quantification within complex biological matrices. The integration of the accuracy profile approach, a statistical tool, enhances the significance of this work. This approach aids in assessing the accuracy and precision of bioanalytical methods, establishing confidence intervals around measured concentrations, and quantifying the level of accuracy and precision expected when using the validated method.

How to cite this paper

 Bouchafra, H., Orche, A., Khabbaz, C., Cheikh, A., Karbane, M., Faouzi, M., Cherrah, Y., Zarayby, L & Hirri, A. (2024). Determination and validation of tiaprofenic acid in human plasma: A detailed LC-MS/MS-based analysis following ICH M10 guidelines and the accuracy profile approach.Current Chemistry Letters, 13(4), 707-716.

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