ISSN print edition: 0366-6352 ISSN electronic edition: 1336-9075 Registr. No.: MK SR 9/7 Published monthly

Nano-level assay of prucalopride by molecular size-based resonance Rayleigh scattering strategy: application to content uniformity test

Mohamed A. Abdel-Lateef, Ibrahim A. Darwish, Rafah M. Thyab, Ryhan J. Darling, and Ahmed A. Abu-hassan

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Al-Azhar University, Assiut Branch, Assiut, Egypt

E-mail: mohamed_abdellateef@azhar.edu.eg

Received: 20 November 2023  Accepted: 3 March 2024

Abstract:

Prucalopride (PCD) is a contemporary medication that was licensed in the USA in 2018 for the relief of constipation induced by motility impairment. PCD exhibits high selectivity and affinity toward the 5-HT₄ receptor. Herein, an ultrasensitive, workable, one-pot experiment, green chemistry compatible approach was implemented for PCD assay. The strategy utilizes molecular size-based resonance Rayleigh scattering phenomena resulting from the dual complex association between Cilefa Pink B and PCD. In an acidic environment, when PCD medication and Cilefa Pink B are mixed, an association complex is immediately created, and dye's RRS is amplified due to molecular size growth. This RRS growth is directly proportional to the PCD concentrations at an interval ranging from 50 to 1300 ng/mL. The RRS signal was monitored at 351 nm. The limit of detection (14.5 ng/mL) and limit of quantitation (43.9 ng/mL) reveal a high approach’s sensitivity. The tunable approach variables were strictly investigated and retrieved. The requirements of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) were applied to the strategy to verify its validity. Additionally, the strategy was successfully applied for PCD analysis in the prescribed dosage form. The use of the established RRS technology to check content uniformity was a noteworthy accomplishment.

Keywords: Prucalopride; RRS; Cilefa Pink B; Tablets; Determination

Full paper is available at www.springerlink.com.

DOI: 10.1007/s11696-024-03402-9

Chemical Papers 78 (8) 4709–4717 (2024)