Bibliographic citations
Rojas, M., (2024). Desarrollo y validación de un método analítico por HPLC para evaluar perfiles de disolución de Losartán Potásico 50mg tabletas [Universidad Nacional de Trujillo]. https://hdl.handle.net/20.500.14414/22475
Rojas, M., Desarrollo y validación de un método analítico por HPLC para evaluar perfiles de disolución de Losartán Potásico 50mg tabletas []. PE: Universidad Nacional de Trujillo; 2024. https://hdl.handle.net/20.500.14414/22475
@misc{renati/884152,
title = "Desarrollo y validación de un método analítico por HPLC para evaluar perfiles de disolución de Losartán Potásico 50mg tabletas",
author = "Rojas Castillo, Mireya",
publisher = "Universidad Nacional de Trujillo",
year = "2024"
}
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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