Thesis (M.Sc.) - Cairo University - Faculty of Pharmacy - Department of Analytical Chemistry

This thesis is concerned with the quantitative determination of some drugs used for treatment of benign prostatic hyperplasia and other coincident diseases. In this thesis, two binary mixtures were studied, separately, in their new pharmaceutical formulations. The first mixture contains Tamsulosin Hydrochloride (TAM) and Tadalafil (TAD), while the second one contains Alfuzosin Hydrochloride (ALF) and Solifenacin Succinate (SOL).The aim of this work was to develop different analytical methods that are characterized by simplicity, accuracy and appropriate degree of sensitivity for the analysis of the above-mentioned drugs in their pure forms, in their pharmaceutical formulations and in the presence of their degradation products and/or potential impurities. Smart UV-spectrophotometric, high-performance thin layer chromatographic (HPTLC) and high-performance liquid chromatographic (HPLC) methods were developed for the analysis of the first mixture (TAM and TAD). Moreover, the principles of green chemistry and Quality-by-Design approach were successfully implemented throughout the chromatographic separation.The greenness profile was assessed via several green metrics as GlaxoSmithKline solvent sustainability guide, environmental, health and safety (EHS) tool, national environmental methods index (NEMI) and Eco-Scale. Additionally, the stability of the two cited drugs was investigated under different stress conditions in accordance with ICH guidelines followed by developing stability-indicating high-performance thin layer chromatographic and high-performance liquid chromatographic methods.The second mixture (ALF and SOL) was assayed by eco-friendly UV-spectrophotometric and Quality-by-Design based HPLC methods in their binary mixtures. In addition, the two enantiomers of ALF were successfully separated along with SOL using 50-mm chiral column and ethanol as green organic solvent.The method was statistically optimized through experimental design. Moreover, stability-indicating high-performance thin layer chromatographic and high-performance liquid chromatographic methods were developed for the simultaneous determination of Alf and SOL along with their official impurities induced via stress stability studies

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