Estabilidad de Dextrometorfano bromhidrato 7,5 mg, pastilla dura para chupar con sabor a Tutti Frutti, realizado en un laboratorio nacional
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Date
2021
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Universidad Nacional de Trujillo
Abstract
El presente informe tiene por objetivo evaluar la estabilidad física, química y microbiológica del Dextrometorfano bromhidrato 7,5 mg sabor Tutti Frutti pastilla dura para chupar, considerando la identificación y valoración del principio activo, características organolépticas, peso promedio y análisis microbiológico. Para la determinación del tiempo de vida útil las muestras fueron sometidas a condiciones de 40ºC ± 2ºC de temperatura y 75% ± 5 % de humedad relativa para el estudio de Estabilidad Acelerada, y 30 ºC ± 2 ºC de temperatura y 65% ± 5% de humedad relativa para el estudio de Estabilidad a Largo Plazo; luego fueron analizadas en sus tiempos establecidos; donde se cuantificó el Dextrometorfano bromhidrato por Cromatografía Liquida de Alta Resolución, método proveniente de la técnica analítica de Dextrometorfano bromhidrato 7,5 mg sabor Tutti Frutti pastilla dura para chupar, método interno. Así mismo, se procedió a estimar la cantidad de principio activo remanente en el producto, respecto al tiempo en meses que se propone; por extrapolación sobre la recta que caracteriza la cinética de degradación del medicamento. Según los resultados obtenidos en el estudio, se logra concluir que el producto en esta formulación es estable y mantiene todos los parámetros que determinan su calidad.
ABSTRACT This report aims to evaluate the physical, chemical and microbiological stability of Dextromethorphan hydrobromide 7.5 mg flavor Tutti Frutti hard pill for sucking, considering the identification and assessment of the active ingredient, organoleptic characteristics, average weight and microbiological analysis. For the determination of the useful life time, the samples were subjected to conditions of 40ºC ± 2ºC of temperature and 75% ± 5% of relative humidity for the accelerated Stability study, and 30 ºC ± 2 ºC of temperature and 65% ± 5% of relative humidity for the long-term stability study; then they were analyzed in their established times; where dextromethorphan bromhydrate was quantified by High Resolution Liquid Chromatography, method from the analytical technique of Dextromethorphan bromhydrate 7.5 mg tutti Frutti flavor hard pill to suck, internal method. Likewise, we proceeded to estimate the amount of active ingredient remaining in the product, with respect to the time in months that is proposed; by extrapolation on the line that characterizes the degradation kinetics of the drug. According to the results obtained in the study, it is possible to conclude that the product in this formulation is stable and maintains all the parameters that determine its quality.
ABSTRACT This report aims to evaluate the physical, chemical and microbiological stability of Dextromethorphan hydrobromide 7.5 mg flavor Tutti Frutti hard pill for sucking, considering the identification and assessment of the active ingredient, organoleptic characteristics, average weight and microbiological analysis. For the determination of the useful life time, the samples were subjected to conditions of 40ºC ± 2ºC of temperature and 75% ± 5% of relative humidity for the accelerated Stability study, and 30 ºC ± 2 ºC of temperature and 65% ± 5% of relative humidity for the long-term stability study; then they were analyzed in their established times; where dextromethorphan bromhydrate was quantified by High Resolution Liquid Chromatography, method from the analytical technique of Dextromethorphan bromhydrate 7.5 mg tutti Frutti flavor hard pill to suck, internal method. Likewise, we proceeded to estimate the amount of active ingredient remaining in the product, with respect to the time in months that is proposed; by extrapolation on the line that characterizes the degradation kinetics of the drug. According to the results obtained in the study, it is possible to conclude that the product in this formulation is stable and maintains all the parameters that determine its quality.
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