Development and validation of a high performance liquid chromatographic-mass/mass method applied to the quality control of ursodeoxycholic acid raw material

BOSCOLO O.; FLOR S; CARRIZO R.; BUONTEMPO F; TRIPODI V.; LUCANGIOLI S.

Rosario

Conferencia; 4° Reunión Internacional de Ciencias Farmacéuticas - RICiFa 2016; 2016

RICIFA

Ursodeoxycholic acid (UDCA) is a secondary bile acid (BA) synthesized in the liver. UDCA decrease the cholesterol content of bile by reducing hepatic synthesis. It is the most used therapeutic agent for treating hepatobiliary cholestatic diseases. In the UDCA raw material may be present other bile acid such as related substances, might be toxic, like lithocholic acid (LCA), and others are associated with numerous side effects such as chenodeoxycholic acid (CDCA). BAs have few chromophore groups in their structure, thus they have low UV-visible response. Therefore, UDCA official USP monograph describes the determination of its related substances such as CDCA and LCA by thin layer chromatography (TLC), using a high UDCA concentration, where each related substance limit should not be more than 1.5% and 0.05% respectively .