Analytical method development and validation for the determination of lurasidone HCL in pharmaceutical dosage form by RP-HPLC
Keywords:Lurasidone HCl, RP-HPLC, Accuracy, Precision, ICH Guidelines.
A simple, accurate, precise and sensitive RP-HPLC assay method have been validated for the estimation of Lurasidone HCl in bulk and marketed pharmaceutical formulation.Lurasidone HCl is separated using Symmetry C18 ODS (4.6mm×150mm) 5µm particle size column and Methanol: Phosphate Buffer (0.05M-pH-4.8) (34:66) used as a mobile phase at a flow rate of 1.0ml/ minand effluent was detected at 315 nm. Here resolution was good, theoretical plate count and symmetry was appropriate. The retention time of Lurasidone HCl was found to be 2.248 minutes. Linearity was observed over concentration range of 30-60ng ml-1. The Limit of detection and limit of quantification was found to be 1.2ng ml-1 and 3.7ngml-1 respectively. The accuracy of the proposed method was determined by recovery studies and found to be 98% to 102%. The above method was afforded excellent percentage recovery was found to be within the limits i.e. 98-102% The % RSD values were less than 2%.The validation parameters, tested in accordance with the requirements of ICH guidelines, prove the suitability of this method. The method was successfully applied for determination of drug in tablets, wherein no interference from tablet excipients was observed, indicating the specificity of the developed method.The proposed method was found to be simple, precise, accurate, rapid, economic and reproducible for the estimation of Lurasidone HCl in bulk and marketed pharmaceutical formulation.