Abstract
Schizophrenia, affecting approximately 1% of the global population, necessitates effective treatments like Lurasidone (LUR). However, the accurate separation of LUR from its enantiomeric impurities remains a significant challenge in pharmaceutical analysis. This study addresses this issue by developing and validating an optimized HPLC method for the simultaneous determination of LUR and its enantiomeric impurity using Analytical Quality by Design (AQbD) principles. The separation was achieved on a Chiralcel OD-H column with isocratic elution employing a hexane-ethanol mixture (92:8, v/v) at a flow rate of 0.9 mL/min, UV detection at 215 nm, and a column temperature of 32 °C. The method was validated using accuracy profiles. Environmental sustainability was assessed using various Green Analytical Chemistry (GAC) metrics, demonstrating favorable greenness attributes. This methodological framework not only enhances pharmaceutical quality control but also promotes sustainability in analytical practices, supporting its application in drug manufacturing and regulatory compliance.
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