Browsing by Author "Dulce Herrera, Laura Camila"
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Item Validación del método de análisis para la determinación de trazas de silimarina por cromatografia hplc-dad en el producto silimarina 150 mg cápsulas, fabricado en una planta farmaceutica, luego de la limpieza en áreas y equipos de fabricación y envase(Universidad Santiago de Cali, 2024) Dulce Herrera, Laura Camila; Flórez Sánchez, Brayan Steven; Ciro Monsalve, Yhors Alexander (Director)Trace determination is used in the pharmaceutical industry to ensure that cleaning processes remove the presence of active ingredients in the equipment used in the manufacturing process at adequate levels. In this way, an HPLC analysis method was validated for the determination of silymarin traces at a wavelength of 280 nm using a Zorbax SB – C18 5 µm 250 x 4.6 mm column (Agilent) maintained at a temperature of 25°. C, under binary gradient elution at a flow rate of 1.0 mL/min. The injection volume was 10µL and methanol was used as diluent. The method was satisfactorily validated in terms of specificity, showing the absence of signals that could interfere with the quantification of the signals of interest. The quantification limit was established at 1.0 ppm, complying with a signal-to-noise ratio greater than 10. The method proved to be linear with r>0.997, in terms of precision an RSD of less than 20.0% was obtained, in terms of accuracy, a recovery of 50% was obtained. The method proved to be robust against the changes made, complying with the evaluated adequacy parameters. F. It was demonstrated that the analytical methodology generates reliable, safe and applicable analytical results for the determination of traces of Silymarin.