Advanced stability-indicating RP-HPLC method for the quantification of lurasidone hydrochloride in bulk and PLGA-based in situ implant formulation.

Objectives: The aims of the present investigation was to develop and validate stability-indicating RP-HPLC method for the estimation of Lurasidone hydrochloride (LURA-H) followed by its drug product, LURA-H encapsulated poly-D,L lactic-glycolic acid (PLGA) based in situ depot forming implant (LURA-H-PLGA-ISI).

Methods: The LURA-H-PLGA-ISI formulation was developed by simple mixing method. According to international conference on harmonization guidelines, RP-HPLC method was developed and validated using Waters 2695 and discovery C18, 5μ, 250×4.6mm ID column. Force degradation studied were performed by various degradation techniques.

Results: The chromatographic separations of LURA-H as well as LURA-H-PLGA-ISI with good resolutions have been achieved using the mobile phase 0.1% orthophosphoric acid and acetonitrile (50:50). The linearity in the range of 25-150 μg/mL of developed method. LOD and LOQ limits for LURA-H were found to be 0.07μg/mL and 0.22μg/mL, respectively. The % RSD was found to be<2% showing the precision of developed method. The accuracy of developed method was demonstrated which is close to 100±2%. Little modifications in the chromatographic conditions indicated robustness of the developed method. Further, solution stability of LURA-H and LURA-H-PLGA-ISI was stable at room temperature. Furthermore, force degradation studies demonstrated LURA-H was unaffected and stable under thermal, photodegradation and neutral (hydrolytic) stress conditions. AGREE and GAPI assessment demonstrated the developed method is environmentally sustainable.

Conclusion: The developed method is simple, robust, precise, accurate and sensitive which can be utilized for the regular analysis of LURA-H in quality control laboratories of bulk drug substance and PLGA containing formulations of LURA-H.