Calidad fisicoquímica de nafazolina clorhidrato 0,03% solución 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 describe los ensayos realizados a nafazolina clorhidrato 0,03% solución oftálmica, con la finalidad de evaluar la calidad fisicoquímica de este medicamento mediante ensayos correspondientes de acuerdo a las especificaciones establecidas por la Farmacopea de Estados Unidos de América USP 43. La muestra estuvo conformada por 60 frascos de soluciones oftálmicas obtenidas aleatoriamente durante el envasado, teniendo resultados lo siguiente: en el aspecto se evidenció una solución transparente, sin color, sin presentar fragmentos o partículas visibles, un volumen promedio de 15,4 mL y pH de 6,04. En la identificación los tiempos de retención de los picos patrones de la solución muestra y solución estándar son 1,84 minutos y 1,83 minutos respectivamente, según corresponde el ensayo de valoración. También presenta un espectro UV de los picos principales de la solución muestra y solución estándar correspondidas entre sí, según se obtenga e el ensayo de valoración. En el ensayo de Valoración se encuentra dentro del rango especificado con 0,330 mg/mL (110,0%). En la prueba de conteo de partículas por obstrucción de luz y en el ensayo valoración de preservante cumplieron con las especificaciones de la USP 43 y propias de la empresa. Se concluyó que nafazolina clorhidrato 0,03% solución oftálmica cumple con las especificaciones consignadas por la USP 43 y propias de la empresa.
ABSTRACT This report on pre-professional practices describes the tests carried out on naphazoline hydrochloride 0.03% ophthalmic solution, with the aim of evaluating the physicochemical quality of this drug through corresponding tests according to the specifications established by the Pharmacopoeia of the United States of America. USP 43. The sample consisted of 60 bottles of ophthalmic solutions obtained randomly during packaging, with the following results: the description showed a transparent solution, colorless, without visible fragments or particles, an average volume of 15, 4 mL and pH of 6.04. In the identification, the retention times of the standard peaks of the sample solution and standard solution are 1.84 minutes and 1.83 minutes, respectively, according to the titration assay. It also presents a UV spectrum of the main peaks of the sample solution and standard solution corresponding to each other, as obtained in the titration assay. In the Titration test it is within the specified range with 0.330 mg/mL (110.0%). In the particle count test due to light obstruction and in the preservative evaluation test, they met the specifications of USP 43 and the company's own. It was concluded that naphazoline hydrochloride 0.03% ophthalmic solution complies with the specifications set forth by USP 43 and the company's own.
ABSTRACT This report on pre-professional practices describes the tests carried out on naphazoline hydrochloride 0.03% ophthalmic solution, with the aim of evaluating the physicochemical quality of this drug through corresponding tests according to the specifications established by the Pharmacopoeia of the United States of America. USP 43. The sample consisted of 60 bottles of ophthalmic solutions obtained randomly during packaging, with the following results: the description showed a transparent solution, colorless, without visible fragments or particles, an average volume of 15, 4 mL and pH of 6.04. In the identification, the retention times of the standard peaks of the sample solution and standard solution are 1.84 minutes and 1.83 minutes, respectively, according to the titration assay. It also presents a UV spectrum of the main peaks of the sample solution and standard solution corresponding to each other, as obtained in the titration assay. In the Titration test it is within the specified range with 0.330 mg/mL (110.0%). In the particle count test due to light obstruction and in the preservative evaluation test, they met the specifications of USP 43 and the company's own. It was concluded that naphazoline hydrochloride 0.03% ophthalmic solution complies with the specifications set forth by USP 43 and the company's own.
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Keywords
Calidad fisicoquímica, producto terminado, nafazolina clorhidrato, solución oftálmica.