Open AccessMETHOD DEVELOPMENT, VALIDATION AND STABILITY STUDIES FOR THE DETERMINATION OF LURASIDONE HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM BY RP-HPLC
Author(s) -
Bhavani Thota,
Geetha Susmita Adepu,
Galla Rajitha
Publication year - 2018
Publication title -
international journal of pharmacy and pharmaceutical sciences/international journal of pharmacy and pharmaceutical sciences
Language(s) - English
Resource type - Journals
eISSN - 2656-0097
pISSN - 0975-1491
DOI - 10.22159/ijpps.2018v10i12.27895
Subject(s) - chromatography , lurasidone , chemistry , dosage form , detection limit , phosphate buffered saline , high performance liquid chromatography , correlation coefficient , calibration curve , retention time , mathematics , computer science , statistics , antipsychotic , programming language , schizophrenia (object oriented programming)
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.