AQbD-Based Robust and Green HPTLC Method for Simultaneous Estimation of Memantine and Galantamine in Smart Long-Acting Injectable Formulation (SLAIF)
Year: 2026
Type: article
Abstract: A greener analytical quality by design (AQbD)-based HPTLC method was developed for the simultaneous quantification of Memantine HCl (MH) and Galantamine HBr (GH) in a smart long-acting injectable formulation. The MH–GH combination offers synergistic cognitive benefits, necessitating a reliable analytical approach for their co-estimation. Chromatographic separation was achieved using chloroform–cyclohexane–methanol–ammonia (5:3:2:0.2, v/v/v/v) as the mobile phase. AQbD principles were implemented by defining the Analytical Target Profile and Critical Analytical Attributes. Robustness was evaluated using a 2⁴⁻¹ fractional factorial design. Distinct and well-resolved bands were obtained at Rf values of 0.56 for GH and 0.28 for MH. The method showed excellent linearity (1500–4000 ng/band; r² > 0.998), precision (RSD < 2%), and accuracy (recoveries 99–101%). The limits of detection and quantification were 63 and 192 ng/band for GH and 88 and 267 ng/band for MH. High greenness scores (BAGI = 80, Analytical Eco-Scale =74) confirmed its eco-friendly nature. The developed AQbD-based HPTLC method is robust, specific, sensitive, and environmentally sustainable, and can be effectively applied for the quantitative analysis of MH and GH in long-acting injectable formulations.
Institution: Gujarat Technological University
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: diamond
OpenAlex ID: W7214935902