Development of HPLC-UV/MS-MS methods applied to the quality control of ursodeoxycholic acid in oral liquid pediatric formulations and raw material.

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

Viena

Conferencia; 7thInternational Conference & Exhibition on Pharmacovigilance; 2016

Conference Series LLC

Ursodeoxycholic acid (UDCA), is a bile acid used to dissolve gallstones and for the treatment of hepatobiliary diseases. It is the only drug approved by the FDA for the treatment of primary biliary cirrhosis.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). USP Pharmacopeia describes the determination of CDCA and LCA by TLC, where each impurity limit should be not more than 1.5% and 0.02% respectively. The aim of this work is to develop, and validate an analytical method by HPLC-UV for the determination of UDCA in oral liquid pharmaceutical formulations with applications in pediatrics. Also, determine the impurities present in the raw material by HPLC / MS-MS.