Examinando por Autor "Gomez Leon, Carmen Rosa"

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    Validación del método analítico por cromatografía líquida de alta performance para la cuantificación de nitazoxanida 100mg/ 5ml polvo para suspensión oral
    (Universidad Privada Norbert Wiener, 2015) Gomez Leon, Carmen Rosa; Ramos Silva, Hesica; Villanueva Vílchez, Hugo Gilberto
    In this research work, the validation of an analytical method for Nitazoxanide 100 mg/5 mL powder for oral suspension was developed using the High-Performance Liquid Chromatography (HPLC) technique. The validation of the method is an indispensable requirement for compliance with Good Laboratory Practices, since it provides reliability to the analytical results obtained in an analytical laboratory, in order to ensure that a medicine complies with the quality parameters established by USP 37. Once the working parameters were defined, the validation protocol of the developed method was carried out, which includes the experimental design and statistical procedures. The quality parameters employed in this validation are: Linearity, which measures the ability of the analytical method to provide results that are directly proportional to the concentration of the analyte, obtaining a correlation coefficient of r = 0.99960. Accuracy, which measures the closeness of the results obtained by this method, with an experimental t (0.633) that is lower than the tabulated t (2.306). Precision, which expresses the degree of agreement or dispersion of the results; the RSD values obtained were 0.697% for method repeatability and 0.913% for intermediate precision. Selectivity, which determines the ability of the method to unequivocally measure the Nitazoxanide content in the presence of other chemical substances that may be present in the sample or degradation products; in the chromatograms of Nitazoxanide, similar retention times were obtained for the sample and the standard. It was demonstrated that the validated analytical method is reproducible, reliable, and can be employed in routine analyses.