Practical and Cost-Effective Process for the Synthesis of Lurasidone Hydrochloride, An-Antipsychotic Drug Through an Efficient Control of Stereo Isomeric Impurities

Manufacturing process reported for the synthesis of Lurasidone hydrochloride are uneconomical, inefficient and practically difficult to operate at industrial scale due to their incapability to control process related and isomeric impurities, more no of synthesis steps, high temperature reaction, huge solvent volume and chromatographic purification makes the process uneconomical, hence need develop cost effective and efficient process for the synthesis of lurasidone hydrochloride. Lurasidone has six chiral centres, and it is necessary to quantify the concentration level of each isomer and specify limits for all isomeric components, impurities, and contaminants for effective application of drugs proposed for intended use. The present work explains about the lurasidone hydrochloride process free from optical isomers and focused on the root of formation of different isomers. Control strategy designed for KRM, KSM, intermediate and finished API. This work also explains the effectiveness of proposed control strategy from laboratory to commercial scale.