Química Farmacéutica

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Validación del método analítico por cromatografía de gases para la cuantificación de acetaldehído en ácido acético natural usado en la industria farmacéutica
(Universidad Santiago de Cali, 2025-10-09) Cañas Cabrera, Jeniffer Sofía; Castillo Ayala, Jorge Enrique (Director)
A gas chromatography method with flame ionization detection (GC-FID) was developed and validated for the quantification of acetaldehyde as an impurity in natural acetic acid. The validation followed USP <1225>, AOAC (2016), and ISO/IEC 17025 guidelines, assessing parameters such as selectivity, limit of detection (LOD), limit of quantification (LOQ), linearity, accuracy, precision (repeatability and intermediate precision), and residual analysis. The method exhibited excellent linearity in the range of 0.0021 to 0.0069 % w/w, with a correlation coefficient of 0.9997. Recovery values ranged from 104.5% to 108.3%, meeting AOAC acceptance criteria for the concentration range studied. Residual analysis confirmed the statistical validity of the linear model. Precision showed coefficients of variation below 5%. In conclusion, the method is sensitive, accurate, precise, robust, and suitable for quality control of natural acetic acid.