Examinando por Materia "Métodos de Análisis de Laboratorio y de Campo"

Mostrando 1 - 5 de 5

Acceso abierto
Factores asociados a peritonitis en pacientes de la unidad de diálisis peritoneal Hospital Guillermo Almenara Essalud, Lima, 2020
(Universidad Privada Norbert Wiener, 2020-12-06) Sanabria Bazán, Esmeralda Lita; Mori Castro, Jaime Alberto
Objetivo General: Analizar los factores asociados a peritonitis en pacientes de la Unidad de Diálisis Peritoneal del Hospital Guillermo Almenara Essalud. Material, Metodos: Enfoque cuantitativo, diseño metodológico no experimental correlacional, corte transversal. Muestreo probabilístico aleatorio simple. Población: Población 242 pacientes, periodo enero - diciembre del 2019. Criterio inclusión mayores 18 años, criterio exclusión menores 18 años. Definición conceptual de variable principal factores asociados a peritonitis: Factores de riesgo como la diabetes, raza, obesidad, climas, infecciones de nariz y estrés. Líquidos peritoneales turbio asumido como peritonitis, debido a inflamaciones del peritoneo por ingreso de microorganismos en la cavidad peritoneal, por rutas intraluminares, transmurales y hematógenas. Definición operacional de variable principal factores asociados a peritonitis: Respuesta obtenida por instrumento Variables Sociodemográficas: Edad, Sexo, Instrucción, responsable del cuidado, procedencia. Clínicas: Tiempo de tratamiento, Enfermedad causante de insuficiencia renal crónica, Modalidad de terapia: DPCA y DPA, Relacionadas a la ocurrencia de Peritonitis: Germen Causal, Numero de episodios. Técnica de recolección de datos Usará ficha de recolección de datos, llevarán al SPSS 25 para análisis, elaboración de tablas y gráficos Métodos de análisis estadístico Aplicará estadística descriptiva, tablas de frecuencias para datos sociodemográficos, y medidas de tendencia central.
Acceso abierto
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.
Acceso abierto
Validación del método analítico para la valoración de paracetamol más ibuprofeno en tabletas recubiertas por HPLC en Laboratorios Vitapharma S.A.C., Lima 2021
(Universidad Privada Norbert Wiener, 2021-08-11) Acosta Guerra, Miguel Angel; Félix Véliz, Luis Miguel Visitación
The present study validated an analytical methodology for the determination of the assay of Paracetamol 500 mg + Ibuprofen 150 mg in coated tablets, conducted in the Quality Control area of Laboratorios Vitapharma S.A.C., thereby demonstrating that the product meets the validation requirements. The objective was to validate the analytical method for the assay of paracetamol combined with ibuprofen in coated tablets by High-Performance Liquid Chromatography (HPLC). The method employed was high-performance liquid chromatography under the following conditions: chromatographic column Lichrospher 100 RP-18 (packing L1) measuring 125 mm × 4 mm (5 μm), flow rate of 0.6 mL/min, temperature of 25°C, detection wavelength of 230 nm, injection volume of 25 μL, and a mobile phase composed of potassium phosphate buffer pH 4.0 and acetonitrile in a 35:65 ratio. The parameters developed included specificity, which demonstrated no significant difference in the response of the active pharmaceutical ingredients (APIs) in the presence of the matrix; linearity, with correlation coefficients greater than 0.999; accuracy, with recovery percentages above 98.0% and within the assigned bias limits; and precision and robustness, with values within the established ranges and coefficients of variation below 2.00%. In conclusion, as all parameters established by official standards were met, the validation of the analytical methodology was considered successfully completed.
Acceso abierto
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.
Acceso abierto
Validación e implementación del método analítico del monitoreo de superficie por hisopado en la industria farmacéutica
(Universidad Privada Norbert Wiener, 2018-10-10) Díaz Fernández, Martha María; Chávez Fernández, Ana María
The present study was carried out with the purpose of evaluating the different methods of surface monitoring carried out in the pharmaceutical industry 2016 - 2017. A Field, Descriptive - Longitudinal, Qualitative and Applied study was carried out. To this end, the parameters were evaluated according to the United States Pharmacopoeia (USP 40 NF 35) Validation of alternative microbiological methods, microorganisms similar to those found were selected (biological standard) in the manufacturing processes of pharmaceutical products, it was evaluated that the working material, the levels of detection were defined and applied to the different methods of surface monitoring in evaluation. It is observed that although the methods do not present homogeneous results; It is considered the method that presents the highest percentage (%) of recovery, in more than one ATCC. It is the Regular Hyssop method of Plastic Soft Nylon Point Sterile Flocked + Shock absorber Solution Sodium Chloride - Peptone. ATCC 9027 (15.30%); ATCC 6538 (41%) and ATCC 8739 (17.4%). That is why this study us to know the importance of importance of identifying and evaluating the proposed methods for the pharmaceutical industry, which is always in constant improvement and innovating in methods to streamline results. The purpose is to avoid false positives or negatives and to guarantee the quality and safety of pharmaceutical products.