METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDIES FOR THE DETERMINATION OF LURASIDONE HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM BY RP-HPLC

Abstract

Objective:  To  develop  a  simple,  rapid,  sensitive,  precise,  accurate,  economical  and  validated reverse  phase  high  performance  liquid  chromatographic  (RP-HPLC)  method  for  the  estimation  of lurasidone hydrochloride in tablet dosage form.Methods:    The  chromatographic  separation  was  carried  out  on  a  prontosil  C18,  AQ  (100 mm×4.6mm,  3µm)  column.  A mixture of phosphate buffer (pH 3.0): acetonitrile (ACN) (55:45v/v) was used as a mobile phase. Flow rate of 1.0 ml/min and 10 μl injection volume was used for the assay.  PDA detector was used and the detection wavelength was 230 nm.  The retention time (RT) of lurasidone hydrochloride was found to be 4.505 ± 0.01 min. The method was validated according to the ICH guidelines.Results:   The   calibration   curve   for   lurasidone   hydrochloride   was   linear   with   correlation coefficient value 0.999 in the concentration range of 25-125%. Specificity, accuracy (% mean recovery, 99.08%), precision, detection limits, robustness (%RSD˂2) and system suitability were found to be within the limits.  Degradation studies were performed under different stressed conditions and the results of degradation studies reveals that the developed method was stable.Conclusion:   The developed method was simple, reliable, economical and stable and it can be applied  for  the  routine  quality  control  analysis  of  lurasidone hydrochloride  in  tablet  dosage forms.