A green chemistry-oriented quality by design approach for sensitive voltammetric determination of ketotifen fumarate using a nano-zirconium oxide-modified electrode

Green method and Quality by Design (QbD) is a systematic approach emphasizing process understanding to ensure drug safety, efficacy, and quality. In line with this, a novel square wave voltammetry (SWV) method was developed for the sensitive quantification of ketotifen fumarate (KTF) in pharmaceutical and biological samples. The method utilized a nanoporous zirconium oxide ceramic electrode (nZrO2-CCE), fabricated with ZrO2 nanoparticles, offering high sensitivity and rapid electrochemical response. Scanning electron microscopy (SEM) and electrochemical characterization confirmed successful electrode fabrication. A QbD framework was applied to identify key variables influencing KTF detection, employing statistical tools such as residual analysis, Box-Cox transformation, perturbation plots, and 3D surface plots. The percentage of nZrO2 emerged as a critical factor, significantly enhancing electrode performance. The developed method exhibited a broad linear detection range (25-2254 ng/mL), low LOD (3.76 ng/mL), and LOQ (11.40 ng/mL). The sensor demonstrated excellent stability, repeatability, and selectivity without interference from excipients or biological matrices. The 7.0% nZrO2-CCE electrode outperformed conventional systems, offering a cost-effective and reliable alternative to techniques like HPLC. This study highlights the successful integration of QbD and nanomaterials to create an efficient platform for KTF quantification in pharmaceutical and clinical settings.

Journal

JOURNAL OF THE INDIAN CHEMICAL SOCIETY

Year

2026

Volume

103

Issue

5

ISSN

0019-4522

DOI

10.1016/j.jics.2026.102538

WoS UID

WOS:001732567500001