Adequabilidade de um metodo analitico por cromatografia líquida de alta eficiência (HPLC) para doseamento de losartana potássica 50 e 100 mg em comprimido revestido

Abstract

Pharmacopeia analytic methods do not require validation, however, there must be documented evidence of their suitability under the laboratory operating conditions. The analytical method of dosing of Losartan Potassium tablets is described in the American Pharmacopoeia. Losartan Potassium is one of the best selling drugs to treat systemic arterial hypertension, being a disease that attacks 1 in 4 adults. The objective of this study was to demonstrate the suitability of the compendial method by proving that it is capable of separating, identifying and quantifying the active (Losartan Potassium) in the presence of potential impurities and degradation products (selectivity); that the method is precise and exact in the quantification range (precision and accuracy); and that the method is robust for small and deliberate changes that may occur in the laboratory routine. The results of the tests meet the criteria of acceptability, proving that the analytical method is selective, precise, exact and robust, therefore it is considered the validated method for the purpose that is proposed.