METHOD DEVELOPMENT, VALIDATION AND STABILITY STUDIES FOR THE DETERMINATION OF LURASIDONE HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM BY RP-HPLC
Objective:Â ToÂ developÂ aÂ simple,Â rapid,Â sensitive,Â precise,Â accurate,Â economicalÂ andÂ validated reverseÂ phaseÂ highÂ performanceÂ liquidÂ chromatographicÂ (RP-HPLC)Â methodÂ forÂ theÂ estimationÂ of lurasidone hydrochloride in tablet dosage form.
Methods:Â Â Â TheÂ chromatographicÂ separationÂ wasÂ carriedÂ outÂ onÂ aÂ prontosilÂ C18,Â AQÂ (100 mmÃ—4.6mm,Â 3Âµm)Â column.Â 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 Î¼l injection volume was used for the assay.Â PDA detector was used and the detection wavelength was 230 nm.Â The retention time (RT) of lurasidone hydrochloride was found to be 4.505 Â± 0.01 min. The method was validated according to the ICH guidelines.
Results:Â Â TheÂ Â calibrationÂ Â curveÂ Â forÂ Â lurasidoneÂ Â hydrochlorideÂ Â wasÂ Â linearÂ Â withÂ Â correlation coefficient value 0.999 in the concentration range of 25-125%. Specificity, accuracy (% mean recovery, 99.08%), precision, detection limits, robustness (%RSDË‚2) and system suitability were found to be within the limits.Â Degradation studies were performed under different stressed conditions and the results of degradation studies reveals that the developed method was stable.Conclusion:Â Â The developed method was simple, reliable, economical and stable and it can be appliedÂ forÂ theÂ routineÂ qualityÂ controlÂ analysisÂ ofÂ lurasidone hydrochlorideÂ inÂ tabletÂ dosage forms.
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