Farmacia y Bioquímica

URI permanente para esta comunidadhttps://hdl.handle.net/20.500.13053/33

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Examinando Farmacia y Bioquímica por Autor "Acosta Guerra, Miguel Angel"

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    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.