Adequabilidade de método analítico para impurezas orgânicas de losartana 50 e 100 mg comprimido revestido

Abstract

The method of losartan 50 and 100 mg for coated tablets was versioned by the United States Pharmacopeial and was evaluated for partial validation. Compendial analytical methods do not require, complete validation, however, prior to implementation, there must be documented evidence of their suitability under laboratory operating conditions. The adequacy of the compendial method was verified through the analysis of selectivity, precision, accuracy and robustness. The results proved that the method is capable of separating, identifying and quantifying the impurities and degradation products of the active, has sufficient sensitivity to quantify the specific and non-specific impurities from its quantification limit, is precise and accurate in the specified range and presents robustness in terms of solution stability.