Chromatographic method development and validation for quantitative determination of ursodeoxycholic acid in ursodeoxycholic acid tablets

Abstract

An HPLC assay method is developed for quantitative determination of ursodeoxycholic acid in ursodeoxycholic acid tablets. The developed method is a simple, accurate, rugged, precise and stability indicating chromatographic method. The stationary phase used in separation of known impurities and ursodeoxycholic acid drug was C18, 250 mm × 4.6 mm, 5 µm. The mobile phase was prepared by mixing of buffer and acetonitrile in the ratio of 50:50 v/v pumped at a flow rate of 1.5mL/min. The developed chromatographic method is validated. The method is accurate, precise and linear over the concentration range of 50-150 %. Mean recovery of ursodeoxycholic acid tablets is found 99.7 ± 0.4. The method is simple and stability indicating, and hence can be used by common laboratories for the determination of ursodeoxycholic acid (assay) in ursodeoxycholic acid ER tablets.