Examinando por Materia "Gentamicinas"

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    Validación del método microbiológico de cilindro-placa para la cuantificación de gentamicina sulfato en Dermolab NF crema de Laboratorios Vitapharma S.A.C., Lima 2018
    (Universidad Privada Norbert Wiener, 2019-06-11) Huerto Huapaya, Carmen Aracelli; Vignolo Asencio, Luis Ernesto; Guevara Vicaña, Rita Aurora
    The present study was conducted with the objective of standardizing a microbiological cylinder-plate method for the quantification of gentamicin and subsequently validating it, that is, to demonstrate through documented evidence in the Quality Control Laboratory of Vitapharma S.A.C. that the product Dermolab NF cream meets the required validation criteria. The validation process was described and developed using the agar diffusion method, with Staphylococcus epidermidis ATCC 12228 as the test microorganism. The analytical parameters evaluated included specificity (selectivity), linearity, range, accuracy, and precision. Statistical evaluation of the experimental results, based on the established acceptance criteria, demonstrated that the analytical method is specific, linear (r² = 0.98 for the standard and r² = 0.97 for the sample, with a minimum specification of 0.95), precise (CV = 2.03% and 1.73%, with a specification of <5%; tolerance = 19.15% and 16.28%, corresponding to repeatability and intermediate precision, respectively, with a specification of <30%), and accurate (bias = 1.06%, with a specification of <3%; G_exp = 0.511 < G_tab = 0.871; T_exp = 0.765 < T_tab = 2.306) within the studied concentration range. Therefore, based on the studies performed, it is established that the analytical performance characteristics meet the requirements for the proposed analytical application, providing reliable results for verifying the quality specifications of the product.