Análisis fisicoquímico de Cetirizina 5 mg/5 mL Jarabe, elaborado en un Laboratorio Nacional, Lima 2018
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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 el análisis fisicoquímico de Cetirizina 5 mg/5 mL Jarabe, elaborado en un Laboratorio Nacional, Lima 2018. Se trabajo con Técnica analítica basada en la monografía de la USP 43, los parámetros analizados fueron: Aspecto, pH, identificación y valoración. Los resultados obtenidos fueron: Aspecto de la muestra: Solución transparente, incolora a ligeramente amarilla con olor a cereza y sabor característico; el pH fue determinado en seis lotes; siendo el promedio de 4,77 (23-25°C); la identificación por HPLC, cumple la especificación, donde el tiempo de retención promedio de los seis lotes analizados del principio activo ( Cetirizina clorhidrato) de la solución en
análisis(14,539)corresponde con el de la solución del estándar( 14,540). Para el ensayo de valoración por HPLC, se preparó dos estándares (número de inyecciones 5 y 2 para cada una) y dos muestras (inyecciones por duplicado para cada una)), obteniendo una concentración final promedio en los seis lotes de 5,07mg/5mL; desviación estándar relativa de 0,71% y un coeficiente de variación de 0,007. Se concluyó que el producto terminado Cetirizina 5mg/5 mL Jarabe, elaborado en un laboratorio nacional cumple con las especificaciones de calidad fisicoquímica según la farmacopea utilizada.
ABSTRACT The objective of this report on pre-professional practices was the physicochemical analysis of Cetirizine 5 mg / 5 mL Syrup, prepared in a National Laboratory, Lima 2018. We worked with an analytical technique based on the monograph of USP 43, the parameters analyzed were: Appearance, pH, identification and assessment. The results obtained were: Appearance of the sample: Transparent, colorless to slightly yellow solution with a cherry odor and characteristic flavor; the pH was determined in six batches; the average being 4.77 (23-25 ° C); the identification by HPLC, meets the specification, where the average retention time of the six analyzed batches of the active principle (Cetirizine hydrochloride) of the solution under analysis (14,539) corresponds to that of the standard solution (14,540). For the HPLC titration test, two standards were prepared (number of injections 5 and 2 for each one) and two samples (injections in duplicate for each one), obtaining an average final concentration in the six batches of 5.07mg / 5mL; Relative standard deviation of 0.71% and a coefficient of variation of 0.007. It was concluded that the finished product Cetirizine 5mg / 5 mL Syrup, prepared in a national laboratory, meets the physicochemical quality specifications according to the pharmacopoeia used.
ABSTRACT The objective of this report on pre-professional practices was the physicochemical analysis of Cetirizine 5 mg / 5 mL Syrup, prepared in a National Laboratory, Lima 2018. We worked with an analytical technique based on the monograph of USP 43, the parameters analyzed were: Appearance, pH, identification and assessment. The results obtained were: Appearance of the sample: Transparent, colorless to slightly yellow solution with a cherry odor and characteristic flavor; the pH was determined in six batches; the average being 4.77 (23-25 ° C); the identification by HPLC, meets the specification, where the average retention time of the six analyzed batches of the active principle (Cetirizine hydrochloride) of the solution under analysis (14,539) corresponds to that of the standard solution (14,540). For the HPLC titration test, two standards were prepared (number of injections 5 and 2 for each one) and two samples (injections in duplicate for each one), obtaining an average final concentration in the six batches of 5.07mg / 5mL; Relative standard deviation of 0.71% and a coefficient of variation of 0.007. It was concluded that the finished product Cetirizine 5mg / 5 mL Syrup, prepared in a national laboratory, meets the physicochemical quality specifications according to the pharmacopoeia used.
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Keywords
Calidad, fisicoquímico,USP, Clorhidrato de cetirizina, HPLC.