Full Validation of the Method Employed to Analyze Oxycodone and Imatinib with LC-MS Using Monte-Carlo Simulation
O. Alami Hamedane*, T. Saffaj, B. Ihssane, R. El hajji, F. Jhilal, Y.Hameda Benchekroun and S. Alaoui Sosse

Application Organic Chemistry Laboratory, Faculty of Sciences and Techniques, BP 2202 immouzer-FEZ- Road-University Sidi Mohamed Ben Abedallah-Morocco

Corresponding Author E-mail: omar.alamihamedane@usmba.ac.ma

Abstract: This work aims to confirm the reliability and applicability of the decision profile as a new overall strategy for the analytical validation and estimation of measurement uncertainty by applying it to the analysis of oxycodone and imatinib using LC-MS. The primary goal of this new approach is to unite two essential criteria prescribed by the ISO IEC 17025, namely analytical validation and estimation of measurement uncertainty, which are required to produce quality results [3]. This innovative approach, recently developed in our laboratory, is defined as a simple and efficient graphical decision-making tool based on the calculation of the tolerance interval of the type "β-γ content" [7,8] using Monte-Carlo simulation. This technique uses the notion of uncertainty instead of accuracy to evaluate the performance of analytical methods, without the need for additional experiments.

Keywords: Analytical validation; Decision profile; Measurement uncertainty; Monte-Carlo simulation; Tolerance interval of type "β-γ content"

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