Análisis fisicoquímico de Elixir de Dexametasona 0,5mg/5ml, en producto terminado de un Laboratorio Farmacéutico Nacional, Lima 2021
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Date
2021
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Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas pre-profesionales tuvo por objetivo realizar el análisis fisicoquímico de elixir de Dexametasona 0,5 mg/5 mL en un producto terminado de un Laboratorio Farmacéutico Nacional, Lima 2021. El muestreo fue aleatorio de 80 unidades del producto Dexametasona 0,5 mg/5 mL Elixir. Se trabajó con la técnica analítica basada en la monografía de la USP 43, que incluye: Descripción, pH, gravedad específica, identificación y valoración. Los resultados obtenidos fueron: Descripción de la muestra: Solución ligeramente siruposo, de color rojo, con olor aromático y sabor particular; pH fue de 3,44 (23-25°C), la gravedad especifica fue de 1,116; la identificación por cromatografía en capa fina cumple la especificación donde el valor Rf del principio activo de la solución en análisis se corresponde con el de la solución del estándar. En la cuantificación por HPLC los tiempos de retención son los correspondientes a Dexametasona y según el ensayo de valoración se encontró una concentración de 0,528mg/5mL de Dexametasona (105,6%). Se concluye que el producto terminado Dexametasona 0,5mg/5ml Elixir, del laboratorio farmacéutico nacional cumple con las especificaciones de calidad fisicoquímica establecidos en la Farmacopea Americana (USP43-NF 38).
ABSTRACT The objective of this pre-professional practice report was to perform the physicochemical analysis of Dexamethasone elixir 0.5 mg / 5 mL in a finished product from a National Pharmaceutical Laboratory, Lima 2021. The sampling was random of 80 units of the Dexamethasone product 0 , 5 mg / 5 mL Elixir. We worked with the analytical technique based on the monograph of USP 43, which includes: Description, pH, specific gravity, identification and evaluation. The results obtained were: Description of the sample: Slightly syrupy solution, red in color, with aromatic odor and particular flavor; pH was 3.44 (23-25 ° C), the specific gravity was 1.116; identification by thin layer chromatography meets the specification where the Rf value of the active principle of the solution under analysis corresponds to that of the standard solution. In the quantification by HPLC the retention times are those corresponding to Dexamethasone and according to the titration test a concentration of 0.528mg / 5mL of Dexamethasone (105.6%) was found. It is concluded that the finished product Dexamethasone 0.5mg /5ml Elixir, from the national pharmaceutical laboratory complies with the physicochemical quality specifications established in the American Pharmacopoeia (USP43-NF 38).
ABSTRACT The objective of this pre-professional practice report was to perform the physicochemical analysis of Dexamethasone elixir 0.5 mg / 5 mL in a finished product from a National Pharmaceutical Laboratory, Lima 2021. The sampling was random of 80 units of the Dexamethasone product 0 , 5 mg / 5 mL Elixir. We worked with the analytical technique based on the monograph of USP 43, which includes: Description, pH, specific gravity, identification and evaluation. The results obtained were: Description of the sample: Slightly syrupy solution, red in color, with aromatic odor and particular flavor; pH was 3.44 (23-25 ° C), the specific gravity was 1.116; identification by thin layer chromatography meets the specification where the Rf value of the active principle of the solution under analysis corresponds to that of the standard solution. In the quantification by HPLC the retention times are those corresponding to Dexamethasone and according to the titration test a concentration of 0.528mg / 5mL of Dexamethasone (105.6%) was found. It is concluded that the finished product Dexamethasone 0.5mg /5ml Elixir, from the national pharmaceutical laboratory complies with the physicochemical quality specifications established in the American Pharmacopoeia (USP43-NF 38).
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Keywords
Dexametasona. Elixir. Cromatografía en Capa Fina. HPLC