Use of Minitab in linearity testing for the validation of an analytical methodology for a dermocosmetic product
DOI:
https://doi.org/10.33448/rsd-v15i5.51046Keywords:
Validation of Analytical Methods, Linearity, ANOVA F-test, Statistical Analysis.Abstract
The validation of analytical methodologies is a fundamental requirement to ensure the quality, reliability, and traceability of results obtained in the quality control of dermocosmetic products. The Linearity parameter is crucial, and its evaluation must be rigorous, transcending the mere verification of the Correlation Coefficient (R). This paper describes the application of advanced statistical tools, using Minitab software, in the detailed evaluation of the assay linearity for the active ingredients of Dermocosmetic Product X. Four actives (Content A, Content B, Content C, and Content D) were evaluated at five concentration levels (60% to 140% of the theoretical concentration), as recommended by guidelines. The analysis included the adjustment of the Ordinary Least Squares (OLS) Regression model, the ANOVA F-test, the evaluation of the Pearson correlation coefficient, and tests for classical residual assumptions (Normality, Homoscedasticity, and Independence). Although all actives showed a high correlation coefficient (R=0.99), the complete statistical analysis identified the rejection of the residual independence hypothesis (autocorrelation) for three of the four actives (Contents A, B, and D), as well as the statistical non-nullity of the intercept. The application of Minitab proved to be an indispensable tool for a complete statistical evaluation, revealing hidden critical non-conformities that an evaluation based solely on R would not detect.
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Copyright (c) 2026 Guilherme do Canto Pereira, Miguel Sant'Anna Dias, Anna Carolina Fontoura Custódio, Moisés Teles Madureira
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