Abstract

GREEN HPTLC AND HPLC: CHALLENGES IN STANDARDIZATION AND PRACTICAL IMPLEMENTATION IN PHARMACEUTICAL ANALYSIS

A. Rajasekaran*, R.S. Keerthi Vasan, V. S. Thiruvengadarajan and R. Arivukkarasu

ABSTRACT

Green analytical chemistry has emerged as a transformative approach for enhancing the sustainability of chromatographic techniques such as high-performance liquid chromatography (HPLC) and high-performance thin-layer chromatography (HPTLC). The replacement of toxic organic solvents with eco-friendly solvent systems, including ethanol, ethyl acetate, and water, significantly reduces environmental impact and improves workplace safety. Recent advancements include the application of Analytical Quality by Design (AQbD), Design of Experiments (DoE), and artificial intelligence-assisted optimization for the development of robust, low-solvent analytical methods. These approaches achieve high resolution, low detection limits, and improved greenness scores, as evaluated using tools such as AGREE, GAPI, and Eco-Scale. Despite these advancements, several challenges remain, including scalability limitations, instrument compatibility issues, regulatory gaps, and data integrity concerns. Variations in solvent properties, increased system backpressure, and limitations of legacy analytical software hinder widespread implementation. This review highlights recent developments in green chromatographic techniques, evaluates greenness assessment tools, and discusses key challenges and future perspectives for the standardization and practical implementation of green HPTLC and HPLC methods.

Keywords: Green Analytical Chemistry; Green Chromatography; HPTLC; HPLC; Method Standardization; Analytical Method Validation.