BAGI‐Validated First Derivative Synchronous Fluorescence Spectroscopy for Sustainable Impurity Profiling of Meclizine: Clinical Implications for Maternal–Fetal Safety

Abstract

This study presents a sustainable analytical methodology for the simultaneous quantification of the antiemetic drug meclizine (MCZ) and its potentially teratogenic impurity 4-chlorobenzophenone (BZP) using first derivative synchronous fluorescence spectroscopy (FDSFS). The method employs a Δλ of 40 nm followed by first derivatization, enabling the selective determination of MCZ at 275 nm and BZP at 311 nm. Given the clinical importance of MCZ in managing nausea and vomiting during pregnancy (affecting 70%-80% of expectant mothers) and the documented reproductive toxicity of the BZP impurity (capable of crossing the placenta and disrupting fetal development), this method addresses a critical safety concern in pharmaceutical quality control. BZP has been linked to adverse reproductive outcomes, hormonal disruption, and developmental toxicity in animal and human studies, making its detection alongside the parent drug imperative for maternal-fetal safety. The practicality and sustainability were quantitatively assessed using the Blue Applicability Grade Index (BAGI), achieving a remarkable score of 80/100, confirming its superior applicability in routine pharmaceutical analysis. This eco-friendly, sensitive, and selective analytical approach represents a significant advancement in the impurity profiling of meclizine used during pregnancy, offering a sustainable tool for pharmaceutical quality assurance with direct implications for maternal and fetal health protection.