Detection and evaluation of process related impurities in obeticholic acid drug material using hplc method

Obeticholic acid (OBE) is being used to treat primary biliary cirrhosis and cholangitis. An HPLC with refractive index detection method for eight process related substances of OBE was developed and verified for use in quality assurance laboratories for regular analysis. The separation and analysis were performed on YMC Triart C18 (3.0 µm particle size, 250 mm x 4.6 mm) column. Mobile phase employed consisted of 0.01N potassium phosphate buffer (3.0 ± 0.05 pH, set with 0.1% orthophosphoric acid) and acetonitrile at 45:55 (v/v) ratio. The method established for determination of eight impurities in OBE was validated and verified in keeping with International Council for Harmonisation guidelines. This method can be used for routine analysis of eight impurities in OBE bulk samples.