Browsing by Author "Diaz Victoria, Danny"
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Item Validación de metodología analítica para la estimación del grado de pureza de fosfato de calcio dibásico anhidro y fosfato de sodio dibásico anhidro, utilizadas como excipientes de productos farmacéuticos(Universidad Santiago de Cali, 2024) Diaz Victoria, Danny; Tusso Pinzón, Ricardo Andrés (Director)The pharmaceutical industry in its constant evolution has developed different formulations, making it necessary to have a great variety of excipients, including inorganic phosphate salts, and since this type of industry requires quality controls that ensure the reliability of the medicine, it is of utmost importance to use appropriate methodologies to evaluate the physical-chemical properties of the excipients. Thus, the objective of this work is to review the performance of a UV-Vis spectrophotometry analysis method to estimate the degree of purity in anhydrous dibasic calcium phosphate and anhydrous dibasic sodium phosphate. To do this, linearity, precision, accuracy, specificity, and robustness are verified. It turns out to be selective for both inorganic salts, linear between 10 ppm and 15 ppm in orthophosphate, with repeatability (%RSD=0.22%), intermediate precision (%CV=0.36%) and accuracy (%recovery=100.5%) acceptable against the USP requirements, together with resistance to different deliberate changes during routine analytical work.