The use of HPLC with various detectors has been reviewed for the analysis of bile acids impurities present in ursodeoxycholic acid preparations. Among detectors used for free bile acid analyses are: electrochemical detector (ED), UV at 210 nm, evaporative light scattering detector (ELSD), fluorescence detector (FLD), and mass spectrometry (MS). A new method was developed for the analysis of the common free bile acids by high-performance liquid chromatography coupled with refractive index detector (HPLC-RI). The compounds were separated on a Kinetex C18 column with a methanol-acetonitrile-phosphate buffer eluent. The method can be used for the analysis of free bile acids in active pharmaceutical ingredients and formulations. |