Desarrollo y validación de un método analítico por HPLC para evaluar perfiles de disolución de Losartán Potásico 50mg tabletas
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Date
2024
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Universidad Nacional de Trujillo
Abstract
La evaluación de perfiles de disolución es esencial para asegurar la calidad y eficacia de los medicamentos. Este trabajo presenta el desarrollo y validación de un método analítico por HPLC para evaluar perfiles de disolución de Losartán Potásico 50mg tabletas, basado en las técnicas establecidas por la FDA. Se trabajó con tabletas de Losartán Potásico 50mg procedentes del medicamento COZAAR, utilizando una columna cromatográfica de 15cm x 4,6mm, 5µm, con relleno L1; la fase móvil consistió en acetonitrilo y ácido fosfórico al 0,1% en agua ultrapura (40:60), con un flujo de 1,5mL/min, volumen de inyección de 20µL, temperatura de 35°C y detección a 254nm; obteniéndose como resultado un tiempo de retención de 4,1 minutos para el analito en los tres medios de disolución y los porcentajes de interferencias fueron <2%. Para linealidad, los coeficientes de correlación y determinación superaron 0,99; con un factor de respuesta <2%. La precisión, mostró un DSR <2% y la exactitud presentó un porcentaje de recuperación entre 95-105%, con un DSR <2%. El método fue robusto en longitudes de onda (253, 254, 255nm) y con diferentes tipos de filtros (PTFE y PVDF), ambos con diferencia absoluta <2%. Las muestras en pH 1,2 y 4,5 fueron estables en refrigeración por 24 horas, mientras que en pH 6,8 se mantuvieron estables a temperatura ambiente y refrigeración hasta 48 horas. El método analítico por HPLC desarrollado cumple los criterios de validación según normas internacionales (FDA) para evaluación de perfiles de disolución de Losartán Potásico 50mg tabletas.
ABSTRACT The evaluation of dissolution profiles is essential to ensure the quality and efficacy of drugs. This work presents the development and validation of an analytical method by HPLC to evaluate dissolution profiles of Losartan Potassium 50mg tablets, based on the techniques established by the FDA. The method was used with Losartan Potassium 50mg tablets from the drug COZAAR, using a 15cm x 4.6mm, 5µm chromatographic column, with L1 packing; the mobile phase consisted of acetonitrile and 0.1% phosphoric acid in ultrapure water (40:60), with a flow rate of 1.5mL/min, injection volume of 20µL, temperature of 35°C and detection at 254nm; the result was a retention time of 4.1 minutes for the analyte in the three dissolution media and the percentages of interferences were <2%. For linearity, the correlation and determination coefficients exceeded 0.99; with a response factor <2%. The precision showed a DSR <2% and the accuracy presented a recovery percentage between 95-105%, with a DSR <2%. The method was robust in wavelengths (253, 254, 255nm) and with different types of filters (PTFE and PVDF), both with absolute difference <2%. The samples at pH 1.2 and 4.5 were stable in refrigeration for 24 hours, while at pH 6.8 they remained stable at room temperature and refrigeration for up to 48 hours. The HPLC analytical method developed meets the validation criteria according to international standards (FDA) for the evaluation of dissolution profiles of Losartan Potassium 50mg tablets.
ABSTRACT The evaluation of dissolution profiles is essential to ensure the quality and efficacy of drugs. This work presents the development and validation of an analytical method by HPLC to evaluate dissolution profiles of Losartan Potassium 50mg tablets, based on the techniques established by the FDA. The method was used with Losartan Potassium 50mg tablets from the drug COZAAR, using a 15cm x 4.6mm, 5µm chromatographic column, with L1 packing; the mobile phase consisted of acetonitrile and 0.1% phosphoric acid in ultrapure water (40:60), with a flow rate of 1.5mL/min, injection volume of 20µL, temperature of 35°C and detection at 254nm; the result was a retention time of 4.1 minutes for the analyte in the three dissolution media and the percentages of interferences were <2%. For linearity, the correlation and determination coefficients exceeded 0.99; with a response factor <2%. The precision showed a DSR <2% and the accuracy presented a recovery percentage between 95-105%, with a DSR <2%. The method was robust in wavelengths (253, 254, 255nm) and with different types of filters (PTFE and PVDF), both with absolute difference <2%. The samples at pH 1.2 and 4.5 were stable in refrigeration for 24 hours, while at pH 6.8 they remained stable at room temperature and refrigeration for up to 48 hours. The HPLC analytical method developed meets the validation criteria according to international standards (FDA) for the evaluation of dissolution profiles of Losartan Potassium 50mg tablets.
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Keywords
Bioequivalencia. Cozaar. Disolución de fármacos. Solubilidad. Cromatografía líquida.