Comparative in vitro assessment of tolterodine tartrate tablets by high performance liquid chromatographic (HPLC)

Tolterodine tartrate, is a new, potent and competitive muscarinic receptor antagonist in clinical development for the treatment of urge incontinence and other symptoms of unstable bladder. The purpose of this study is to establish a reliable and quick method for the assignment of tolterodine tartrate by high performance liquid chromatography with ultraviolet detection (HPLC-UV). A rapid  and  sensitive  high  performance  liquid  chromatographic  (HPLC)  method  has  been developed  for  determination  of  tolterodine tartrate.  Mobile phase was composed of phosphate acetate ۰.۱ M (pH ۲.۵)-acetonitrile (۵۰:۵۰ v/v) with a flow rate of ۱.۲ ml/min. The eluted peaks were detected by a UV detector was set at wavelength of ۲۸۵ nm. The method was validated in the range of tolterodine tartrate concentrations from ۱۰ to ۱۰۰ µg/ml. The limits of detection (LOD) and quantitation (LOQ) of the method were ۵ and ۱۰ µg/ml, respectively. The average drug recovery was ۹۸.۲۰ % throughout the linear concentration range. The average within-run and between-run accuracy values of ۹۸.۵۶ % and ۹۹.۱۱ % respectively. Statistical  assessment  of  various  in  vitro  dissolution  parameters  and  assay  results was  also  conducted  to  establish  if  there were  any significant difference among them. The validated HPLC method has been used successfully to study tolterodine tartrate.

کلیدواژه ها:

Tolterodine tartrate ، HPLC ، assay ، dissolution