Examinando por Materia "Cromatografía Liquida"
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Publicación Acceso abierto Desarrollo y validación de una metodología analítica para la cuantificación de fexofenadina 30mg/5ml suspensión oral por cromatografía líquida de alta resolución (HPLC)(Universidad Privada Norbert Wiener, 2021-08-05) Maravi Armas, Jessica; Grimaldo Medina, Elisabeth Lourdes; Segura Vílchez, Tito MagnoThe Analytical Method used in a Finished Product today must maintain the highest quality parameters of the laboratories, controlling the quality and reliability, ensuring that the validation process must comply with current standards. Objective: Demonstrate that the analytical method developed for the quantification of Fexofenadine 30mg / 5mL Oral Suspension by High Performance Liquid Chromatography meets the established performance parameters. Methodology: This analytical test study for an analytical technique validation is of an applied, descriptive, quantitative type and of a longitudinal and prospective design. Results: It was verified that the verification of the evaluated parameters was in accordance with their results of System Suitability, Selectivity, Stability, Accuracy, System and Method Linearity, Intermediate Precision, Instrumental Repeatability, Method Repeatability and Robustness, meeting their acceptance criteria established for an Analytical Method Validation. Conclusion: That the analytical method for the quantification of Fexofenadine 30mg/5mL Oral Suspension by high performance liquid chromatography HPLC meets the statistical results required for validation, demonstrating reliability.
