Advanced stability-indicating RP-HPLC method for the quantification of lurasidone hydrochloride in bulk and...

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).

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.

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.

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.