Calidad fisicoquímica de prednisolona acetato 1% suspensión oftálmica de un laboratorio farmacéutico nacional
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas pre profesionales, tuvo por objetivo evaluar la calidad fisicoquímica del producto, para lo cual se utilizan una serie de análisis y parámetros de acuerdo a la vigente Farmacopea de los Estados Unidos de América USP 43. Para la muestra se tomaron 60 frascos del producto, que fueron obtenidas aleatoriamente durante el envasado. Los resultados fueron los siguientes: para la descripción se observó una suspensión blanca de aspecto homogéneo, con un volumen promedio de 5,1mL y pH de 5,75. En la identificación por cromatografía de capa fina se obtuvo que el valor Rf de la mancha principal obtenida de la muestra corresponde a la mancha obtenida de la solución estándar. En la valoración los resultados fueron de 10,40mg/mL (104%). En el ensayo de osmolalidad se adquirió un promedio de 306 mOsm/Kg. Se concluye que prednisolona acetato 1% suspensión oftálmica cumple con las especificaciones detalladas en la USP 43 y sus protocolos propios.
ABSTRACT The purpose of this pre-professional practice report was to evaluate the physicochemical quality of the product, for which a series of analyzes and parameters are used in accordance with the current Pharmacopoeia of the United States of America USP 43. For the sample, 60 jars of the product, which were randomly obtained during packaging. The results were as follows: for the description, a white suspension with a homogeneous appearance was observed, with an average volume of 5.1 mL and a pH of 5.75. In the identification by thin layer chromatography, it was obtained that the Rf value of the main stain obtained from the sample corresponds to the stain obtained from the standard solution. In the assessment, the results were 10.40mg/mL (104%). In the osmolality test, an average of 306 mOsm/Kg was acquired. It is concluded that prednisolone acetate 1% ophthalmic suspension complies with the specifications detailed in USP 43 and its own protocols
ABSTRACT The purpose of this pre-professional practice report was to evaluate the physicochemical quality of the product, for which a series of analyzes and parameters are used in accordance with the current Pharmacopoeia of the United States of America USP 43. For the sample, 60 jars of the product, which were randomly obtained during packaging. The results were as follows: for the description, a white suspension with a homogeneous appearance was observed, with an average volume of 5.1 mL and a pH of 5.75. In the identification by thin layer chromatography, it was obtained that the Rf value of the main stain obtained from the sample corresponds to the stain obtained from the standard solution. In the assessment, the results were 10.40mg/mL (104%). In the osmolality test, an average of 306 mOsm/Kg was acquired. It is concluded that prednisolone acetate 1% ophthalmic suspension complies with the specifications detailed in USP 43 and its own protocols
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Keywords
Suspensión oftálmica, Prednisolona