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.
Highlights
Lurasidone hydrochloride, chemically (3aR, 4S, 7R, 7aS)-2-{(1R, 2R)-2[4-(1, 2benzisothiazol-3-yl) piperazin1ylmethyl] cyclohexylmethyl} hexahydro-4, 7-methano-2H-isoindole-1, 3-dione is a potent antipsychotic drug belonging to the class of benzothiazole derivatives
Lurasidone hydrochloride acts as an antagonist at Dopamine type-2 (D2) and 5-hydroxytryptamine (5HT2A) receptors
The chromatographic separation with good retention was carried on Shimadzu LC AHT 2010 HPLC system with a prontosil C18 column of dimensions 100 mm x 4.6 mm and particle size 3 μm
Summary
Lurasidone hydrochloride, chemically (3aR, 4S, 7R, 7aS)-2-{(1R, 2R)-2[4-(1, 2benzisothiazol-3-yl) piperazin1ylmethyl] cyclohexylmethyl} hexahydro-4, 7-methano-2H-isoindole-1, 3-dione is a potent antipsychotic drug belonging to the class of benzothiazole derivatives. It is used for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults and for the treatment of schizophrenia. Lurasidone hydrochloride acts as an antagonist at Dopamine type-2 (D2) and 5-hydroxytryptamine (5HT2A) receptors. It has moderate antagonistic activity at alpha 2C-and alpha 2A-adrenergic receptors and is a partial agonist at 5HT1A receptors. This medication exhibits minimal or no affinity for histamine type-1 (H1) or muscarinic type-1 (M1) receptors
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