Validación de un método espectrofotométrico UV/Vis para estudios de bioequivalencia in vitro de tabletas de isoniazida 100 mg
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El presente informe tuvo como finalidad validar el método espectrofotométrico UV/Vis para estudios de bioequivalencia in vitro de tabletas de isoniazida 100 mg. Se utilizó 100 tabletas de isoniazida 100 mg y se realizaron las lecturas en el espectrofotómetro UV/Visible - PERKIN ELMER, LAMBDA 25 a una longitud de onda de 263 nm para los tres medios de disolución (pH 1,2; 4,5 y 6,8). La validación del método analítico se realizó tomando en consideración lo descrito en la Farmacopea de Estados Unidos 42, la Conferencia Internacional de Armonización y la Asociación Española de Farmacéuticos de la Industria. Los parámetros de validación evaluados fueron: linealidad del sistema y del método, exactitud, precisión (repetibilidad y precisión intermedia), selectividad, robustez, interferencia de filtro y estabilidad. Los resultados demostraron que el método analítico es lineal con un r2 > 0,99; es exacto con un promedio recuperado dentro del rango establecido (95 – 105 %); es preciso y robusto con un coeficiente de variación porcentual < 2 % y es selectivo con un porcentaje de interferencia < 2 %. Además, se observó que no hubo interferencia de filtro con un coeficiente de variación porcentual < 2 % y que la muestra analizada es estable hasta las 12 horas. Se concluye que el método analítico cumple con las especificaciones establecidas en las guías oficiales; por lo tanto, se da por validado el método espectrofotométrico UV/Vis para estudios de bioequivalencia in vitro de tabletas de isoniazida 100 mg.
ABSTRACT The purpose of this report was to validate the UV/Vis spectrophotometric method for in vitro bioequivalence studies of isoniazid 100 mg tablets. 100 tablets of 100 mg isoniazid were used and the readings were made in the UV/Visible spectrophotometer - PERKIN ELMER, LAMBDA 25 at a wavelength of 263 nm for the three dissolution media (pH 1.2; 4.5 and 6.8). The validation of the analytical method was carried out taking into consideration what is described in the United States Pharmacopeia 42, the International Conference on Harmonization and the Spanish Association of Industry Pharmacists. The validation parameters evaluated were: system and method linearity, accuracy, precision (repeatability and intermediate precision), selectivity, robustness, filter interference and stability. The results showed that the analytical method is linear with r2 > 0.99; is accurate with an average retrieved within the stated range (95 – 105%); it is accurate and robust with a percentage variation coefficient < 2% and it is selective with an interference percentage < 2%. In addition, it was observed that there was no filter interference with a percentage variation coefficient < 2% and that the analyzed sample is stable up to 12 hours. It is concluded that the analytical method complies with the specifications established in the official guides; therefore, the UV/Vis spectrophotometric method for in vitro bioequivalence studies of isoniazid 100 mg tablets is considered validated.
ABSTRACT The purpose of this report was to validate the UV/Vis spectrophotometric method for in vitro bioequivalence studies of isoniazid 100 mg tablets. 100 tablets of 100 mg isoniazid were used and the readings were made in the UV/Visible spectrophotometer - PERKIN ELMER, LAMBDA 25 at a wavelength of 263 nm for the three dissolution media (pH 1.2; 4.5 and 6.8). The validation of the analytical method was carried out taking into consideration what is described in the United States Pharmacopeia 42, the International Conference on Harmonization and the Spanish Association of Industry Pharmacists. The validation parameters evaluated were: system and method linearity, accuracy, precision (repeatability and intermediate precision), selectivity, robustness, filter interference and stability. The results showed that the analytical method is linear with r2 > 0.99; is accurate with an average retrieved within the stated range (95 – 105%); it is accurate and robust with a percentage variation coefficient < 2% and it is selective with an interference percentage < 2%. In addition, it was observed that there was no filter interference with a percentage variation coefficient < 2% and that the analyzed sample is stable up to 12 hours. It is concluded that the analytical method complies with the specifications established in the official guides; therefore, the UV/Vis spectrophotometric method for in vitro bioequivalence studies of isoniazid 100 mg tablets is considered validated.
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Validación, Espectrofotometría UV/Vis, Isoniazida