Abstract

METHOD DEVELOPMENT AND VALIDATION OF LURASIDONE HCL IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY U.V SPECTROPHOTOMETRY

Apparasu Sravani Kasyap*, Pulusu Veera Shakar and Kallakuntla Bhavana

ABSTRACT

The UV-spectroscopic method was developed and validated for the estimation of Lurasidone HCl in accordance with ICH guidelines. A simple fast accurate and precise UV-spectroscopy method was developed by using Methanol: Water (70:30) was used as the solvent in method 1 and Acetonitrile: Water (50:50) was used as solvent in method 2. The λmax 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. The accuracy studies of UV-spectroscopy was performed at three different levels, i.e., 50%, 100%, and 150% and recovery was found to be in the range of 100.1-100.6% and 99.2. The limit of detection (LOD) and limit of quantification (LOQ) were found for UV-spectroscopy. The % RSD is <2% which indicates the accuracy and precision of the method. The above method was a rapid tool for routine analysis of Lurasidone in the bulk and in the pharmaceutical dosage form.

Keywords: UV-spectroscopic method, correlation coefficient, limit of quantification.