الفهرس | Only 14 pages are availabe for public view |
Abstract The thesis comprises four main parts describing the theoretical and practical aspects of the investigated analytical methods: Part I: General Introduction This part contains a general introduction about lipoprotein disorders and antihyperlipidemic drugs. Part II: Stability Indicating TLC Method for the Determination of Rosuvastatin and Identification of Some Degradation Products Using Electrospray Ionization Mass Spectrometry. The second part involves the development of a simple stability indicating thin layer chromatographic (TLC) method for the determination of rosuvastatin calcium. The developed TLC method involved the separation of rosuvastatin and the degradation products released under different stress condition. Successful separation was achieved using aluminium plates pre-coated with silica gel 60F254 as a stationary phase and chloroform: n-hexane: methanol: glacial acetic acid (8:10.4:1.5:0.1 v/v/v/v) as a developing system. The chemical electrospray ionization mass spectrometry. The method was successfully applied for the determination of rosuvastatin in bulk and tablets without any interference from its degradation products. Part III: Simultaneous Analysis of Rosuvastatin and its Stress Degradation Products Using Liquid Chromatography Coupled to UV and Electrospray Ionization Mass Spectrometry Detector. Part III involves a comprehensive study of the degradation behavior of rosuvastatin calcium under different stress condition using liquid chromatography coupled to ultraviolet detection and electrospray ionization mass spectrometry (LC-UV-ESI-MS). Successful separation of the drug and degradation products was achieved on a Zorbax Eclipse Plus C18 column using acetonitrile: 0.1% formic acid in water (40:60, v/v) as the mobile phase. Simultaneous ultraviolet and mass spectrometric detection provided an advantageous tool to make a highly sensitive quantitative assay of the degradation products and to investigate their chemical structures. The mass spectrometric response factors of potential degradation products were concluded by a simple statistical procedure. The proposed method was successfully applied on commercial tablets concerning drug assay and purity testing. |