Greenness and whiteness evaluation of HPTLC methodology for simultaneous assay of aceclofenac and paracetamol in fixed-dose combination tablet dosage forms

This study establishes and validates a sustainable reverse-phase “high-performance thin-layer chromatography (HPTLC)” methodology for the concurrent assay of aceclofenac (ACC) and paracetamol (PCT) in their fixed-dose combination (FDC) tablets. A green developing system with a 70:30 (v/v) ratio of ethanol and water was used to assess ACC and PCT simultaneously. The methodology was validated for numerous validation parameters following standard regulatory guidelines. The method’s greenness and whiteness profiles were assessed using four different metrics: “the analytical eco-scale (AES), chloroform toxicity (ChlorTox), the analytical GREEnness (AGREE) and the blue applicability grade index (BAGI)”. The suggested method was linear for both drugs in the 25–1,200 ng/band level. Following validation, the suggested method was determined to be precise, accurate, robust, sensitive, and sustainable. The results from all the greenness and whiteness tools, such as AES (93), ChlorTox (0.72 g), AGREE (0.75), and BAGI (85), demonstrated that the developed method had a notably greener and whiteness profiles. The ACC and PCT levels in commercial FDC tablets were found to be within the limit of 100 ± 2 % using the suggested methodology. The investigation’s findings demonstrated that the suggested technique could accurately analyze the levels of ACC and PCT in commercial FDC tablets.