Validação de metodologia analítica para doseamento e substâncias relacionadas em azitromicina (matéria-prima) por cromatografia liquida de alta eficiência (HPLC)

Abstract

A linear response was obtained for the assay of azithromycin in the range of 80 to 120% of the nominal concentration of the method obtaining R=0,9987. The method presented accuracy with maximum RSD of 1,05%. The method showed selectivity, being possible to separate and identify azithromycin safely. Degradation susceptibility of azithromycin exposed to acidic, basic and oxidative media was visualized. In all the robustness conditions evaluated, deliberate variations did not have a negative impact on the quantification. Azithromycin showed stability in solution of up to 25 hours. For the quantification of the related substances, it was possible to identify and separate all possible impurities to be found in the raw material, without coeluition of impurities with the active. The impurities obtained by forced degradation were quantified, and the degradation occurred in the same media mentioned for assay. The accuracy of the method was obtained with a maximum DPR of 1.98% and the average recovery was close to 100% with a maximum DPR of 1.80%. The limit of quantification of the method was 0.10%.