Abstract B8
Screening for Corticosteroids in Pharmaceutical Products by HPLC

John C. Reepmeyer. Division of Testing and Applied Analytical Development, FDA, St. Louis, MO.

A simple liquid chromatographic method was developed for the screening of corticosteroids. About 50 steroids, most of which were glucocorticosteroids, were analyzed by reversed-phase HPLC with mobile phase gradients created from either acetonitrile-water or methanol-water. Steroids which were unresolved with one gradient system were often resolved with the second. For example, prednisone and hydrocortisone were unresolved with MeCN-H2O (Rs = 0), but well resolved with MeOH-H2O (Rs = 4.4). Structural assignments based on retention times were supported by spectra provided by a rapid scanning UV detector. Because of differences in polarity and solubility of tested steroids, three extraction protocols were developed to enhance steroid recovery from different sample matrices.