Development and validation of a LC-UV Method Applied to the Quality Control of Ursodeoxycholic Acid in Raw Material and Pharmaceutical Formulations

Abstract

A simple, fast, and sensitive HPLC method with UV detection has been developed for the quantitation of ursodeoxycholic acid (UDCA) in raw material and pharmaceutical formulation (suspension). Cromatographic conditions were: Symmetry-C18 column (150 mm x 4.6 mm, id; particle size 5 µm), 40 ˚C, 100 µL injection volume and UV detection at 200 nm. The flow rate was 1 ml/min using acetonitrile - phosphoric acid (pH 3.0; 0.15mM) (48:52) as mobile phase. The method was validated according to international guidelines (ICH guidelines) for specificity, linearity, LOD, LOQ, precision, accuracy, and robustness. The HPLC-UV method was found to be suitable for the quality control of UDCA raw material and pharmaceutical formulation.