SYNTHESIS, CHARACTERIZATION, AND ANALYTICAL STUDIES OF ADOSUPINE, A POTENTIAL NEW DRUG FOR URINARY-INCONTINENCE

The synthesis and the spectroscopic characterization of a new potentia l drug for urinary incontinence, adosupine, is described. Adosupine an d its potential synthesis impurities were analyzed by a new HPLC metho d that was developed with a C-18 reversed-phase column. The analysis w as made under isocratic conditions, with a mobile phase of acetonitril e:water (15:85, v/v). Resolution of all synthesis impurities was allow ed. The method was also applied to stability studies of adosupine in s olid state and in solution under different conditions. With the condit ions used, only one degradation product was shown by HPLC analysis; it was isolated, characterized, and identified as the hydrolysis product of the lactam ring present in the adosupine structure.