METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDIES FOR THE DETERMINATION OF LURASIDONE HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM BY RP-HPLC
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×4.6 mm, 3 µm) 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 a 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 limits. Degradation studies were performed under different stressed conditions, and the results of degradation studies reveal 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.
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