Development of a micellar electrokinetic chromatography system applied to the quality control of ursodeoxycholic acid in oral liquid pediatric suspensions

BOSCOLO O.; ESTEVEZ PABLO; MARTINEFSKI M.,; TRIPODI V.; LUCANGIOLI S.

Cordoba

Jornada; 3ª Reunión Internacional de Ciencias Farmacéuticas; 2014

Introduction: Ursodeoxycholic acid (UDCA), also known as ursodiol, is a secondary bile acid which is synthesized in the liver. UDCA lowers the cholesterol content of bile by reducing hepatic synthesis and reabsorption by the gut. Bile acids are derivatives hydroxylated 5β-cholan-24-oic acid, which are characterized by the absence of chromophore groups in its structure, which results in low absorption in the UV-visible region.In UDCA raw material may be present as impurities other bile acids, some of them toxic, like lithocholic acid (LCA), and others associated with numerous side effects such as chenodeoxicholic acid (CDCA). The official USP monograph describes the determination of related compounds such as CDCA and LCA by thin layer chromatography (TLC), where each impurity limit should not be more than 1.5% and 0.05% respectively. Purpose: the aim of this study was to optimize an analytical method by electrokinetic chromatography using cyclodextrins and micellar agents for determination of ursodeoxy cholic acid and its impurities in pharmaceutical pediatric suspensions.