{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["12(1)"],"submitter":["Muchakayala SK"],"funding":["Inyuvesi Yakwazulu-Natali","University of KwaZulu-Natal"],"pubmed_abstract":["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 KH<sub>2</sub>PO<sub>4</sub>) (MP-A), initial gradient composition (% MP-A), flow rate (mL min<sup>-1</sup>), and column oven temperatures (°C) are 4.05, 87, 0.4, and 30, respectively. The best possible separation between th"],"journal":["Scientific reports"],"pagination":["19138"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9646803"],"repository":["biostudies-literature"],"pubmed_title":["AQbD based green UPLC method to determine mycophenolate mofetil impurities and Identification of degradation products by QToF LCMS."],"pmcid":["PMC9646803"],"pubmed_authors":["Saripella KK","Schaaf H","Marisetti VM","Muchakayala SK","Jonnalagadda SB","Katari NK","Kowtharapu LP"],"additional_accession":[]},"is_claimable":false,"name":"AQbD based green UPLC method to determine mycophenolate mofetil impurities and Identification of degradation products by QToF LCMS.","description":"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 KH<sub>2</sub>PO<sub>4</sub>) (MP-A), initial gradient composition (% MP-A), flow rate (mL min<sup>-1</sup>), and column oven temperatures (°C) are 4.05, 87, 0.4, and 30, respectively. The best possible separation between th","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Nov","modification":"2025-04-19T10:37:15.153Z","creation":"2025-04-19T10:37:15.153Z"},"accession":"S-EPMC9646803","cross_references":{"pubmed":["36352016"],"doi":["10.1038/s41598-022-22998-0"]}}