Robust analytical method for the enantiomeric separation of lurasidone hydrochloride: Integrating analytical quality by design and green chemistry principles

• Published in: Sustainable chemistry and pharmacy 2024-12, Vol.42, p.101788, Article 101788
• Main Authors: Babaker, Manal A., Algohary, Ayman M., Ibrahim, Ahmed M.
• Format: Article
• Language: English
• Subjects: Analytical quality by design (AQbD); Capability analysis; Design of experiment (DoE); Enantiomeric separation; HPLC-UV method
• ISSN: 2352-5541; 2352-5541
• DOI: 10.1016/j.scp.2024.101788

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. [Display omitted] •Employed Analytical Quality by Design (AQbD) principles to develop a robust HPLC.•Separating Lurasidone and its Enantiomeric Impurity.•Our method adheres to SFSTP guidelines for method validation.•Evaluated greenness metrics using various tools.