AQbD based green UPLC method to determine mycophenolate mofetil impurities and Identification of degradation products by QToF LCMS.

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 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 th

SUBMITTER: Muchakayala SK 

PROVIDER: S-EPMC9646803 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature