The objective of pre-formulation study is to develop the elegant, stable, effective and safe injectable microsphere dosage form by establishing kinetic profile, compatibility with other formulation excipients and physico-chemical parameters of Lurasidone Hydrochloride (LRH). This could provide important information for formulation design or support the need for molecular modification. So, in the present study pre-formulation studies were performed on LRH to assess its suitability for parenteral formulation. LRH is a potent and benzoisothiazol derivatives used as anti-psychotic. The authenticity of the drug was established by UV maximum wavelength, HPLC retention time, Melting point, DSC and FTIR spectra. Along with this chloride salt form is confirmed by Chloride test. A UV spectrophotometric method and HPLC method were employed for determination of LRH in bulk active pharmaceutical ingredient (API). The UV method was linear in the range of 5-30 μg/ml. The retention time of LRH in HPLC method was found to be 11.6 min. The method was proven robust by obtaining very high regression coefficient value (0.999). Drug compatibility of Drug with Excipient had been proved by DSC and FTIR spectra. The results of the physicochemical study of drug revealed suitability of LRH for parenteral route microsphere in PLGA polymer with use of compatible solvent like Dichloromethane.

Pre-formulation, Lurasidone HCl (LRH), HPLC, UV, Drug polymer compatibility, FT-IR, DSC, Solubility