Browsing by Author "Zapata Salcedo, Gina Marcela"
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Item Validación de un método analítico para la cuantificación de impurezas orgánicas de Lisinopril en el producto Lisinopril 10 mg tabletas, por cromatografía líquida de alta resolución (HPLC) y detector UV-PDA(Universidad Santiago de Cali, 2024) Zapata Salcedo, Gina Marcela; Diaz Peláez, Juan Sebastián; Ciro Monsalve, Yhors Alexander (Director)The purpose of the following work is to obtain a suitable and accessible chromatographic method for the quantification of known and unknown organic impurities in the Lisinopril 10mg Tablet product. For this, it was proposed to carry out the validation of an analytical method, by high performance liquid chromatography (HPLC) and UV-PDA detector. Evaluating 8 performance parameters in accordance with what is indicated by the ICH-Q2 and chapter 1225 of the United States Pharmacopeia – National Formulary (USP-NF): System suitability, specificity, selectivity, stability of the analyte in solution, linearity, accuracy, precision and range. Following the analytical parameters indicated in the USP-NF 2022 Edition Lisinopril monograph