Examinando por Materia "Análisis Espectral"
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Publicación Acceso abierto Aplicación de la espectroscopía en el infrarrojo cercano – NIR para el análisis cualitativo del principio activo naproxeno sódico(Universidad Privada Norbert Wiener, 2015) Auccapuclla Chuquihuaccha, Sindy; Navarro Juárez, Pascuala Elizabeth; Palomino Fernández, EdgarNear-infrared spectroscopy (NIR) was applied in the pharmaceutical industry with the aim of proposing an alternative instrumental method for the qualitative analysis of the active ingredient Naproxen Sodium. For the proposed method, a library was created containing active pharmaceutical ingredients with structural formulas of propionic acid anti-inflammatory derivatives, as well as active ingredients with similar physical characteristics, making a total of 19 inputs included in the library. To establish the method, the primary packaging of the input was first identified, and five different batches previously approved by the traditional method and compared against a primary standard were selected. Once the spectra were acquired, they were processed using the Savitzky–Golay filter to minimize spectral noise, followed by a spectral matching algorithm and subsequently classified based on the k-nearest neighbors (k-NN) method. Internal and external validation of the proposed method was carried out in accordance with USP <1225> guidelines, category 4. The fundamental performance attribute validated for the identification test was selectivity (specificity), defined as the ability of a method to selectively discriminate the identity of the chosen analyte from all potential interfering substances. This method is relevant as it reduces sampling and analysis time, while also minimizing analyst exposure and preventing the input from being exposed to the environment.
