Analytical Method Development and Validation for the Estimation of Ursodeoxycholic Acid using RP-HPLC

The Present work is undertaken with an aim to develop and validate an accurate, precise and rapid method for the estimation of Ursodeoxycholic Acid in tablet and bulk dosage form. The method is simple, accurate and sensitive. The separation was achieved on a gradient high pressure liquid chromatograph (Jasco, RI 2031 Plus) pumps Jasco PU 2080 Plus, IR detector column oven (Jasco), system controller (Jasco), a disposable guard column LC-18 (PELLIGUARD)TM , LC-18, 2 cm, supelco, inc., Bellefonte, and a Reverse Phase C-18 (phenyl) Column (25 cm x 4.6 mm) i.d., particle size 5 ?m) was used The HPLC system was equipped with the software class, Borwin (Jasco). Flow Rate : 1.0 ml/min Injection Volume : 10?l Run Time : 15 min, Detector temp: 40 oC. The method was validated for specificity, precision, linearity, and accuracy. The recovery range for baclofen is in the range of 99.0?102.0% and the method can be successfully applied for the routine analysis of the drug substance.