biostudies-literatureUnknown12(1)Muchakayala SKInyuvesi Yakwazulu-NataliUniversity of KwaZulu-NatalWe report an ideal method for quantifying impurities in mycophenolate mofetil drug substances and their oral suspension preparations. We developed a systematic and eco-friendly analytical approach utilizing quality by design (QbD) and green chemistry principles. Initially, the critical method parameters (CMPs) were screened using a D-optimal design. The robust final method conditions were optimized using a systematic central composite design (CCD). Through graphical and numerical optimization, the protocol conditions were augmented. The pH of mobile phase buffer (25 mM KH₂PO₄) (MP-A), initial gradient composition (% MP-A), flow rate (mL min^-1), and column oven temperatures (°C) are 4.05, 87, 0.4, and 30, respectively. The best possible separation between thScientific reports19138https://www.ebi.ac.uk/biostudies/studies/S-EPMC9646803biostudies-literatureAQbD based green UPLC method to determine mycophenolate mofetil impurities and Identification of degradation products by QToF LCMS.PMC9646803Saripella KKSchaaf HMarisetti VMMuchakayala SKJonnalagadda SBKatari NKKowtharapu LPfalseAQbD based green UPLC method to determine mycophenolate mofetil impurities and Identification of degradation products by QToF LCMS.We report an ideal method for quantifying impurities in mycophenolate mofetil drug substances and their oral suspension preparations. We developed a systematic and eco-friendly analytical approach utilizing quality by design (QbD) and green chemistry principles. Initially, the critical method parameters (CMPs) were screened using a D-optimal design. The robust final method conditions were optimized using a systematic central composite design (CCD). Through graphical and numerical optimization, the protocol conditions were augmented. The pH of mobile phase buffer (25 mM KH₂PO₄) (MP-A), initial gradient composition (% MP-A), flow rate (mL min^-1), and column oven temperatures (°C) are 4.05, 87, 0.4, and 30, respectively. The best possible separation between th2022-01-01T00:00:00Z2022 Nov2025-04-19T10:37:15.153Z2025-04-19T10:37:15.153ZS-EPMC96468033635201610.1038/s41598-022-22998-0