Assay and Quality control.

A simple isocratic RP-HPLC method was developed for the estimation of Lurasidone in bulk and pharmaceutical dosage forms by using Waters (Alliance) HPLC (2695 series) System operated with Empower software-2. The optimized chromatographic conditions were found to be buffer of 0.05% Trifluroacetic acid in 0.01 M Potassium dihydrogen orthophosphate solution, mobile phase of buffer and acetonitrile in the ratio 60: 40, Inertsil ODS, C18, 150mm x 4.6mm, 5µ particle size HPLC column at temperature of 30°C, 20 µL of injection volume, 1.0ml/min flow rate and UV detector with detection wavelength 231nm. Retention time and peak area of standard or sample were found to be 5.428min or 5.431 min. and 4128545 or 4126122 respectively. System precision and method precision were found to be less than 2.0%. The method was found to be linear within the limits 2.5-15.0µg/ml with good correlation coefficient 0.9999. The percent of recovery (accuracy) was found from 99.34 to 99.97%. Ruggedness and robustness studies were carried out and the results were found to be satisfactory. Stability of Lurasidone was studied under the different stressed conditions and found to be stable (96.37-93.55%). The % of assay of different dosage of Latuda tablets was found between 99.68 -100.18%. The proposed method was found to be sensitive, precise, accurate, linear, rugged and robust, and applied for the analysis of pharmaceutical formulations and percent of assay was evaluated, hence the proposed method can adopt for the routine analysis in any quality control laboratory.