Stability Indicating RP-HPLC Method for Determination and Validation of Lurasidone HCL in Bulk and Pharmaceutical Dosage Forms

Abstract

Objective: To develop and validate a simple, selective, rapid and stability indicating reverse phase high performance liquid chromatographic (RP-HPLC) method for the analysis of Lurasidone HCl in bulk and its tablet dosage forms. Method : Several trials were made by changing the mobile phase composition and nally the drug was resolved on a Thermo ODS, C18, (150 × 4.6 mm, 5μ) column, using the mobile phase consisting of sodium dihydrogen ortho phosphate buffer (pH 6.5) and acetonitrile in 60 : 40 ratio and pumped at a ow rate of 0.8 ml/min at ambient temperature. Studies were performed on Waters HPLC system equipped with PDA detector, the response was monitored at 230 nm. The developed method was validated as per ICH guidelines. Results : The retention time of Lurasidone HCl was found to be 3.33±0.02 minutes. The calibration curve was linear over the concentration range of 10-60 μg/ml (r 2 =0.9999). The limit of detection for Lurasidone HCl was found to be 0.25 μg/ml and the quantication limit was about 0.75 μg/ml. The accuracy of the method was established based on the recovery studies and the percentage recovery was in the range of 99.95 to 100.01. The drug was degraded in all the conditions like acid, alkali, oxidative, thermal and photolytic conditions by proposed RP-HPLC method. Research Value : The proposed method can be applied for the routine analysis of Lurasidone HCl in bulk and its pharmaceutical dosage forms in quality control laboratory.