GREEN ANALYTICAL APPROACH FOR DEVELOPMENT AND VALIDATION OF AN HPTLC METHOD FOR QUANTIFICATION OF BUPROPION HYDROCHLORIDE IN TABLET DOSAGE FORM AND ITS GREENNESS ASSESSMENT

Objective: The present study aimed to develop and validate a simple, rapid and environmentally acceptable HPTLC method for the quantitative estimation of bupropion hydrochloride in tablet dosage form and to evaluate its greenness profile using AGREE, GAPI, NEMI and Analytical Eco-scale tools. Methods: Chromatographic separation was achieved on silica gel 60 F254 precoated aluminium plates using methanol: chloroform: glacial acetic acid (1.5:8.5:0.3, v/v/v) as the mobile phase. Densitometric analysis was performed at 252 nm after a chamber saturation time of 15 min. The method was validated according to ICH Q2(R1) guidelines. Results: Bupropion hydrochloride exhibited a compact spot with an Rf value of 0.37 ± 0.001. The method showed linearity over the concentration range of 150–350 ng/band with a correlation coefficient of 0.9984. The assay of marketed tablets was found to be 98.44%. The recovery range was –%, indicating good accuracy. Precision studies showed %RSD values below 2%, confirming method precision. The LOD and LOQ were found to be 7.36 ng/band and 22.31 ng/band, respectively. Robustness studies indicated that small deliberate variations had no significant effect on chromatographic performance. Greenness assessment demonstrated an AGREE score of 0.69, Eco-scale score of 66 and favourable GAPI and NEMI profiles. Conclusion: The developed HPTLC method is simple, precise, accurate and suitable for routine quality control analysis of bupropion hydrochloride tablets. The greenness assessment indicated that the proposed procedure represents an environmentally acceptable analytical approach with reduced solvent consumption and waste generation.