Examinando por Autor "Flores Palma, Germán Antonio"

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    Validación del método analítico para la cuantificación de levocetirizina diclorhidrato 5mg/mL solución oral gotas por cromatografía liquida de alta precisión
    (Universidad Privada Norbert Wiener, 2018-12-03) Flores Palma, Germán Antonio; Núñez Soto, Daniel Martín; Ramos Jaco, Antonio Guillermo
    In the validation of the analytical method for the quantification of Levocetirizine Dihydrochloride 5 mg/mL oral drop solution by High-Performance Liquid Chromatography (HPLC), several parameters were assessed. Linearity was demonstrated by obtaining a correlation coefficient of r = 0.998 for the system and 0.9996 for the method, values that exceed the minimum permissible limit of 0.995. Accuracy was evaluated using the Student’s t-test, yielding a texp value of 1.1444, which is lower than the tabulated value of 2.306; therefore, no significant difference was found between the mean recovery and the amount added, indicating that the percentage recovery is close to 100%. Precision was confirmed by the relative standard deviation (RSD) values obtained, which were 0.19% for repeatability and 0.52% for intermediate precision, both well within the maximum allowed RSD of 2.0%. Specificity was also established, as the chromatographic peaks obtained showed similar retention times for both the sample and the standard, confirming the specificity of the method. Furthermore, analysis of the standard and placebo demonstrated that no excipients interfered with the active ingredient peak, nor was the presence of degradation products of Levocetirizine Dihydrochloride detected under forced degradation conditions. These results confirm that the method is selective.