Method Development and Validation for Estimation of Ursodeoxycholic Acid in Tablet Dosage form by HPLC

Ursodeoxycholic acid (UDCA) is a pharmaceutical ingredient widely used in clinics. As bile acid it solubilizes cholesterol gallstones and improves the liver function in case of cholestatic diseases. The HPLC method for determination of assay of ursodeoxycholic acid tablet had been validated for precision, accuracy (recovery) & Linearity. In the present study, an attempt was made to provide a newer, simple, sensitive, precise, accurate stability and low cost HPLC method for the effective quantitative determination of ursodeoxycholic acid as an active pharmaceutical ingredient as well as in pharmaceutical preparations without the interferences of other constituent in the formulations. HPLC method is developed and validated for various parameters as per ICH guidelines. The validated method was effectively useful to the commercially accessible pharmaceutical dosage form, yielding extremely good and reproducible result.