Advanced approaches for development and optimization of robust analytical methods and some relevant industrial applications / Mohamed Ahmed Mohamed Gad ; Supervised Sawsan Mohamed Amer , Hala Elsayed Zaazaa , Said Abdelmonem Hassan

Thesis (Ph.D.) - Cairo University - Faculty of Pharmacy - Department of Analytical Chemistry

The modern analytical chemistry paradigm pays special attention to robustness and transferability of the analytical methods, this thesis concerns with sound science development of specific, robust and transferable analytical methods.This work presents integration of advanced mathematical and chemometric techniques in the process of development and optimization of the analytical methods.The utilized techniques were simplex optimization and response surface methodology, desirability function, principal component regression, partial least square regression, neural networks, support vector machine and non-linear bayesian calibration. Several industrial problems were investigated: first, high variance associated with cleaning validation worst case as result of being function of manufacturer and current product portfolio. Second, lack of stability studies and sound science robust stability indicating method for determination of daclatasvir.Third, formulation instability of azilsartanmedoxomil/chlorthalidone tablet dosage form, lack of sound science robust stability indicating methods either chromatographic or spectrophotometric for determination of azilsartanmedoxomil/chlorthalidone in the presence of realistic degradation products. Fourth, handling of the curvy-linear potentiometric profile for ion selective electrodes, application on ISE fabricated for determination of daclatasvir in pharmaceutical formulations.The developed methods were successfully applied for routine work in quality control analysis and stability assessment of the investigated drugs in pharmaceutical formulation

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