Development and Validation of UV Spectrophotometric Method for Estimation of Lurasidone in Bulk and Pharmaceutical Formulations

The UV-spectroscopic method were developed and validated for the estimation of Lurasidone HCl as per ICH guidelines. A simple, fast, accurate and precise UV-spectroscopy method was developed by using methanol: water (70:30v/v) and acetonitrile: water (50:50v/v) was used as the solvent in both methods. The λ_max of Lurasidone was found to be 230 nm and it was proved linear in the concentration range of 2.5-15 μg/ml with a correlation coefficient value of 0.999 for both the methods. The accuracy studies of UV-spectroscopy method was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range of 99.2 to 102.4% respectively. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.61-0.69 for both UV Method. The % RSD is <2% which indicates the accuracy and precision of the method.