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Abstract The thesis deals with the analysis of some selected drugs of various pharmacological classes and biological molecules bearing acidic function(s) and belonging to non steroidal anti-inflammatory agents, antiepileptics, sympathomimetic drugs and therapeutically applicable bile acids. The thesis comprises five parts: Part I This part contains a general introduction about the chemical names, structures, physical properties, pharmacological actions and therapeutic uses of the studied drugs. It also contains literature reviews for the pharmacopoeial and other reported methods of analysis for the selected drugs in pharmaceutical dosage forms, biological samples and other possible matrices. Part 11 This part describes two stability-indicating methods for analysis of loxoprofen sodium using HPTLC and HPLC-DAD. This part includes two chapters. Chapter 1: This chapter deals with the development of a simple stability-indicating HPTLC procedure for the assay of loxoprofen sodium. Effective separation was obtained using Merck TLC silica gel aluminum plates 60 F254 and n-hexane / chloroform / methanol (40:40:20, by volume) as mobile phase followed by densitometric measurement of loxoprofen spots at 225 run where the drug appears as compact spots at Rr 0.50±0.03. Analytical performance of the proposed method was validated with respect to linearity, range, precision, accuracy, specificiry, robusmess, daeaic» suid tpmm!iJ:ieafjO)p~ LiP~,rV’~ge’(J1fI&ITIprof&r )’7J-ZSOO ng/spot with correlation coefficient> 0.9999. The drug was subjected to acidic, basic, oxidative, wet heat and dry heat degradation conditions. The proposed method was proved to be stability-indicating by resolution of the drug from its forced degradation products. Moreover, specificity of the method was verified by resolution of loxoprofen from some closely related pharmaceutical compounds. The validated method was successfully applied to the analysis of the tablet dosage form. Chapter 2: It presents the selective stability-indicating determination of loxoprofen sodium using HPLC-DAD. Good separation was achieved using Pinnacole DB C8 column (4.6x 150 mm, 5 urn particle size) with isocratic elution of the mobile phase composed of 0.05 Mo-phosphoric acid solution and methanol (40:60, by volume). The mobile phase was pumped at a flow rate 1 mLlmin and quantification of loxoprofen was based on peak area measurement at 220 nm. The drug peak eluted at retention time 4.095±0.005 min. Calibration curve of loxoprofen was linear in the range 15-225 ug/ml, with correlation coefficient > 0.9999. Analytical performance of the proposed procedure was validated according to the ICH guidelines with respect to linearity, range, precision, accuracy, specificity, robustness, detection and quantification limits. The drug was subjected to the previously mentioned degradation conditions where it showed considerable degradation in basic and oxidative conditions. |