Quality assurance in extemporaneously compounded formulations: a titration method for ursodeoxycholic acid

OBJECTIVE — To validate an acid-base titration method, adopted from the British Pharmacopoeia, for analysis of ursodeoxycholic acid (UA) in extemporaneously compounded formulations. METHODS — Two different extemporaneously compounded formulations containing UA 15mg/ml, prepared from both pure drug and Actigall capsules were compared. A series of titrations was carried out to validate the titration method, as per International Conference on Harmonisation (ICH) guidelines. The titration method was used to analyse the stability of the UA suspensions stored for six weeks under ICH accelerated stability conditions. RESULTS —The titration method was found to be specific and accurate. Differences between the initial drug concentration of the two suspensions and the concentration after six weeks at accelerated stability conditions were statistically insignificant, indicating stability of the formulations. CONCLUSION — A simple acid-base titration method adopted from the British Pharmacopoeia has been validated to determine UA content in extemporaneously compounded suspensions, and can be recommended for quality assurance testing in hospital pharmacy.