Evaluación de la presencia de Nitrosamina en Losartan almacenadas en diferentes farmacias del sector sur de la ciudad de Guayaquil
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2024
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Universidad de Guayaquil. Facultad de Ciencias Químicas
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En este estudio se evaluó la cantidad de nitrosaminas en el medicamento losartán de 50 mg almacenadas en diferentes farmacias del sector sur de Guayaquil. La degradación de sus impurezas puede ocurrir debido a la exposición a diversas condiciones de almacenamiento y la presencia de estas representa un gran riesgo para la salud de las personas, ya que son consideradas altamente cancerígenas. Para la parte experimental se analizaron un total de 27 blísteres de losartán de tres fabricantes, estos permanecieron durante tres meses en diferentes condiciones ambientales. La cuantificación de las nitrosaminas se realizó por la técnica de HPLC con detector PDA y los resultados se compararon con los límites máximos permitidos proporcionados por la FDA. Al analizar las muestras de las diferentes farmacias se demostró que las tabletas expuestas a estrés térmico presentan valores ligeramente aumentados de impureza NDMA en comparación con las otras condiciones, la impureza NDEA fue detectada en las condiciones de exposición a la luz solar y estrés térmico ambas impurezas no sobrepasan el límite, mientras que la impureza NBMA no se detectó en ninguna condición. Por otro lado, al comparar las muestras por fabricantes se observa que en los fabricantes A y C hubo un aumento de impurezas en la exposición a la luz solar y el estrés térmico. Se concluye que las condiciones de almacenamiento influyen en la presencia de nitrosaminas en el medicamento losartán, especialmente las temperaturas altas, por lo cual se debe realizar un control adecuado para garantizar que este sea seguro.
In this study, the amount of nitrosamines in the medicine losartan stored in different pharmacies in the southern sector of Guayaquil was evaluated. The degradation of its impurities can occur due to exposure to various storage conditions and the presence of these represents a great risk to human health, since they are considered highly carcinogenic. For the experimental part, a total of 27 blisters of losartan 50 mg from three manufacturers were analyzed; these remained for three months in different environmental conditions. The quantification of nitrosamines was carried out by the HPLC technique with a PDA detector and the results were compared with the maximum allowed limits provided by the FDA. When analyzing the different pharmacies, it was shown that the tablets exposed to thermal stress have slightly increased values of NDMA impurity compared to the other conditions, the NDEA impurity was detected in the conditions of exposure to sunlight and thermal stress, both impurities do not exceed the limit, while the NBMA impurity was not detected under any condition. On the other hand, when comparing the results by manufacturers, it is observed that in manufacturers A and C there was an increase in impurities in exposure to sunlight and thermal stress. It is concluded that storage conditions influence the presence of nitrosamines in the drug losartan, especially high temperatures, which is why adequate control must be carried out to ensure that it is safe.
In this study, the amount of nitrosamines in the medicine losartan stored in different pharmacies in the southern sector of Guayaquil was evaluated. The degradation of its impurities can occur due to exposure to various storage conditions and the presence of these represents a great risk to human health, since they are considered highly carcinogenic. For the experimental part, a total of 27 blisters of losartan 50 mg from three manufacturers were analyzed; these remained for three months in different environmental conditions. The quantification of nitrosamines was carried out by the HPLC technique with a PDA detector and the results were compared with the maximum allowed limits provided by the FDA. When analyzing the different pharmacies, it was shown that the tablets exposed to thermal stress have slightly increased values of NDMA impurity compared to the other conditions, the NDEA impurity was detected in the conditions of exposure to sunlight and thermal stress, both impurities do not exceed the limit, while the NBMA impurity was not detected under any condition. On the other hand, when comparing the results by manufacturers, it is observed that in manufacturers A and C there was an increase in impurities in exposure to sunlight and thermal stress. It is concluded that storage conditions influence the presence of nitrosamines in the drug losartan, especially high temperatures, which is why adequate control must be carried out to ensure that it is safe.
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NITROSAMINAS, LOSARTÁN, FDA