Influencia de la temperatura y humedad relativa en las características fisicoquímicas de dicloxacilina sódica materia prima
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Date
2021
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Universidad Nacional de Trujillo
Abstract
El objetivo de la presente investigación fue determinar la influencia de la temperatura y Humedad relativa en las características fisicoquímicas de Dicloxacilina sódica materia prima. Para realizar dicha investigación se almaceno Dicloxacilina sódica materia prima a condiciones de Temperatura y humedad relativa las cuales fueron: 20ºC ± 5ºC/70% ± 5%, 30ºC ± 2ºC/ 65% ± 5%, 40ºC ± 2ºC/75% ± 5% por periodos de tiempos de 1, 10, 20 y 30 días. Para lo cual se identificó Dicloxacilina materia prima mediante el método de absorción en el infrarrojo, se determinó la cristalinidad por el método del microscopio. Se realizó la valoración de Dicloxacilina sódica materia prima por el método de cromatografía liquida de alta eficacia (HPLC), se determinó la humedad por titulación Karl Fischer, se determinó el pH mediante el uso del potenciómetro. Los resultados fueron comparados con la farmacopea Norteamericana (USP 42). Los resultados de la identificación en todas las temperaturas y humedad relativa son conformes, en la prueba de cristalinidad, se observó que en todas las temperaturas y humedad relativa se formaron cristales, en la valoración de Dicloxacilina sódica materia prima se observó una disminución de 874 μg/mg a 862 μg/mg, en la Humedad se observó un incremento de 4.39 a 5.01, en el pH se observó una disminución de 5.5 a 5.1. Concluyendo que la temperatura y humedad relativa no influye significativamente en las características fisicoquímicas de identificación por infrarrojo y cristalinidad, valoración y humedad de dicloxacilina sódica materia prima, resultando en un incremento de Humedad, y en una disminución de la valoración, por lo contrario en las características fisicoquímicas del pH de dicloxacilina sódica materia prima, resultando en una disminución del pH.
ABSTRACT The objective of this research was to determine the influence of temperature and relative humidity on the physicochemical characteristics of Dicloxacillin sodium raw material. To carry out this research, Dicloxacillin sodium raw material was stored at conditions of temperature and relative humidity which were: 20ºC ± 5ºC/70% ± 5%, 30ºC ± 2ºC/ 65% ± 5%, 40ºC ± 2ºC/75% ± 5% for periods of 1, 10, 20 and 30 days. For which Dicloxacillin raw material was identified by the infrared absorption method, crystallinity was determined by the microscope method. Dicloxacillin sodium raw material was titrated by high performance liquid chromatography (HPLC), moisture was determined by Karl Fischer titration, pH was determined by potentiometer. The results were compared with the North American pharmacopoeia (USP 42). The results of the identification at all temperatures and relative humidity are in accordance, in the crystallinity test, it was observed that at all temperatures and relative humidity crystals were formed, in the titration of Dicloxacillin sodium raw material a decrease was observed from 874 μg/mg to 862 μg/mg, in the Humidity an increase was observed from 4.39 to 5.01, in the pH a decrease was observed from 5.5 to 5.1. Concluding that temperature and relative humidity do not significantly influence the physicochemical characteristics of infrared identification and crystallinity, titration and moisture of dicloxacillin sodium raw material, resulting in an increase in Moisture, and a decrease in titration, on the contrary in the physicochemical characteristics of pH of dicloxacillin sodium raw material, resulting in a decrease in pH
ABSTRACT The objective of this research was to determine the influence of temperature and relative humidity on the physicochemical characteristics of Dicloxacillin sodium raw material. To carry out this research, Dicloxacillin sodium raw material was stored at conditions of temperature and relative humidity which were: 20ºC ± 5ºC/70% ± 5%, 30ºC ± 2ºC/ 65% ± 5%, 40ºC ± 2ºC/75% ± 5% for periods of 1, 10, 20 and 30 days. For which Dicloxacillin raw material was identified by the infrared absorption method, crystallinity was determined by the microscope method. Dicloxacillin sodium raw material was titrated by high performance liquid chromatography (HPLC), moisture was determined by Karl Fischer titration, pH was determined by potentiometer. The results were compared with the North American pharmacopoeia (USP 42). The results of the identification at all temperatures and relative humidity are in accordance, in the crystallinity test, it was observed that at all temperatures and relative humidity crystals were formed, in the titration of Dicloxacillin sodium raw material a decrease was observed from 874 μg/mg to 862 μg/mg, in the Humidity an increase was observed from 4.39 to 5.01, in the pH a decrease was observed from 5.5 to 5.1. Concluding that temperature and relative humidity do not significantly influence the physicochemical characteristics of infrared identification and crystallinity, titration and moisture of dicloxacillin sodium raw material, resulting in an increase in Moisture, and a decrease in titration, on the contrary in the physicochemical characteristics of pH of dicloxacillin sodium raw material, resulting in a decrease in pH
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Keywords
Materia prima. Dicloxacilina sódica. Características fisicoquímicas