Desenvolvimento e validação de métodos para o controle analítico do anti-helmíntico ricobendazole®

Abstract

This study aims to develop and validate an analytical method for quantification of albendazole sulfoxide in Ricobendazole® product by high performance liquid chromatography (HPLC) ensuring product quality and consumer safety. The HPLC method with which it was possible to quantify the albendazole sulfoxide was carried out employing a phase C18, 250x4, 6 mm, 5μm, Gemini®, and mobile phase of sodium acetate buffer 0.05M pH 5.0 : Acetonitrina (75:25), flow rate 1.0 ml / min and UV detection at 290 nm, the retention time was 5.5 min active and the total time of the analytical run was 10 min. The correlation coefficient (r) of 0.9994, the result recovery method considering an overall mean of three concentrations was 99% linear response range from 80 to 120 μg.mL-1 detection limit of 0.3 μg.mL-1 and the quantitation limit 1.0 μg.mL-1, the results of intermediate precision and robustness show variations lower than 2%. The method was later covalidado efficiency ultra chromatography (CLUE) while maintaining the same mobile phase Mobile phase: Buffer 0.05 M Sodium Acetate: Acetonitrile (75:25) BEH® C18 stationary phase (50mmx2, 1mmx1, 7μm) , flow rate 0.21 mL / min. UV detector 290 nm, retention time was 1.0 min active and the total time of 4.0 min analytical run. The method can be considered efficient, fast and reliable to be used in routine analysis of quality control Ricobendazole®.