الفهرس 
INTRODUCTIONOnly 14 pages are availabe for public view
Abstract
The thesis comprisesfive main parts:
Part I:
This part includes a review of green chemistry, analytical chemistry and chromatography. Inthis review, green chemistry definition, importance, principles and some recent applications werediscussed.
<In addition, the review summarizes the evolution of green analytical chemistry with its specific principles and how to make the analytical process more environmentally benign withspecial emphasis on recent applications of green analytical chemistry.
<Moreover, green chromatography, its methods and some ofits applications were outlined.
<Finally, differenttechniques available up till now for the assessment of the greening of the methods were als opresented.
<Part II This part presents an introduction regarding the chemical names, structures, molecular weight,physical properties and pharmacological actions and uses of the studied drugs(Donepezilhydrochloride and Lacosamide).
<It also includes a literature review of the reported methods ofanalysis of the selected drugs, in pharmaceutical dosage forms as well as in biological fluids.
<Part III :In this partanovel,simple, eco-friendly, stability-indicating HPLC method was developed forthe determination of Donepezil Hydrochloride (DH) in tablet dosage formsin presence of itspharmacopoeial related compound (Donepezil related compound A) and its different degradationproducts.
<The chromatographic conditions were optimized to achieve the highest performance parameters. The method was validated according to the ICH guidelines with respect to systems uitability, specificity, linearity,accuracy,precision, ruggedness, robustness, detection andquantitation limits. Forced degradation studies were performed on standard DH and test Demepezil®5 mg tablets under various conditions and the method was found to be stability
Summary 184 indicating. The purity of the DH peak was confirmed using the DAD. In the developed method twoprinciples of green chromatography were adopted (reduce and replace) by reducing solventconsumption through the utilization of a short column (10 cm) with a smaller particle size (3.5μ m) instead of a normal 25 cm with a 5 μm particle size and by replacing hazardous solvents ofthe official USP method as acetonitrile with ethanol.
Furthermore, the greenness of the methodwas assessed using National Environmental Methods Index label,Analytical eco scale andEnvironmentalassessmenttool.
Part IV :
This part describesthedevelopmentand validationof a new, reliable,sensitive,green, simpleand costeffectivechemometric UVspectrophotometric method for correcting interferencesthatarise during conducting biowaiver studies.
<Chemometric manipulation has been done forenhancing the results of direct absorbance, resulting from very low concentrations (high incidenceof background noise interference)of earlier points in the dissolution timing in case of dissolutionprofile using first and second derivative (D1& D2) methods and their corresponding Fourierfunction convoluted methods (D1/FF& D2/FF).
<The method applied for biowaiver study ofDHasa representative modelwas doneby comparing two different dosage forms containing 5 mg DHper tablet as an application of a developed chemometric method for correcting interferences aswell as for the assay and dissolutiontestingintablet dosage forms.
The results showed that firstderivative technique can be used for enhancement of the data in case of low concentration range ofDH (1-8 μ g ml-1) in the three different pH dissolution media which were used to estimate the lowdrug concentrations dissolved at the early points in the biowaiver study. Furthermore, the resultsshowed similarity in phosphate buffer pH 6.8 and dissimilarity in the other two pH media.
< Themethod was validated according to ICH guidelines and USP monograph for both assays (in pH1.2) and dissolution study in three pH media (HCl pH 1.2, acetate buffer pH 4.5 and phosphatebuffer pH 6.8). Finally, the assessment of the method greenness was done using two different assessment techniques: National Environmental Method Index label and Eco scale. Bothtechniques proved the greenness of the proposed method.
Part VThis partdiscussesthe development ofadirect, eco-friendly, stability-indicating GC methodfor the determination of Lacosamide (LCM) in tablet dosage forms in presence of its degradationproducts as well as in human urine in presence of the co-administered drug Zonisamide (ZON).
<The assay method in tablets was validated according to the ICH guidelines, while the method fordetermination of LCM in urine was validated according to FDA; Bioanalytical Method Validation
<Summary 185 guidance.
The investigation of LCM forced degradation behavior was carried outunder variousstress conditions.
Furthermore, monitoring of the drug in urine followed by construction of itsurine profile was done after the administration of 50 mg tablet of LCM to three healthy volunteersso as to prove the ability of the method to beapplied in assaying LCM in human urine.
Themethod showed also successful separation of LCM and the co-administered drug ZON in urine.
Finally, the greenness of the method was assessed using National Environmental Methods Index label andAnalytical eco scale.
The thesis consists of 218 pages and comprises 56 tables,55figures and 246 references.