Estimation of Measurement Uncertainty in Assay of Active Pharmaceutical Ingredient by HPLC Using GUM Approach: Development of Excel Model
1 National Laboratory for the Control of Medicines, Ministry of Health, Tunisia.
2 Department of Mathematics, Ministry of Education, Tunisia.
3 Department of Mathematics, Faculty of Sciences of Tunis, University of Tunis El Manar, Tunisia.
Research Article
International Journal of Biological and Pharmaceutical Sciences Archive, 2025, 10(02), 121–128.
Article DOI: 10.53771/ijbpsa.2025.10.2.0071
Publication history:
Received on 03 August 2025; revised on 07 November 2025; accepted on 10 November 2025
Abstract:
The evaluation of measurement uncertainty is a major concern in pharmaceutical analysis, particularly for quantitative assays performed using high-performance liquid chromatography (HPLC). This study aims to estimate the uncertainty associated with the assay of an active pharmaceutical ingredient (API) by applying the methodology outlined in the Guide to the Expression of Uncertainty in Measurement (GUM), in accordance with international standards for analytical method validation . HPLC is widely used due to its accuracy, precision, and robustness . Estimating the combined and expanded uncertainty is essential to ensure the reliability of the analytical results . To support the routine application of this approach, an Excel template was developed to perform similar uncertainty calculations in pharmaceutical laboratories.
Keywords:
Measurement uncertainty; GUM approach; HPLC; Modelling; Excel template
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Copyright © 2025 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0