Please use this identifier to cite or link to this item: http://hdl.handle.net/10603/242651
Title: Development And Validation of Analytical Methods For The Estimation of Drugs Used In The Treatment of Arthritis
Researcher: JIGNASHA MAHESHKUMAR DERASARI
Guide(s): VANDANA B PATEL
Keywords: Clinical Pre Clinical and Health,Pharmacology and Toxicology,Pharmacology and Pharmacy
University: Gujarat Technological University
Completed Date: 
Abstract: quotPresent research investigation deals with the development of analytical methods and their validation of drugs used in the treatment of arthritis. Four combinations i.e. 1) Diclofenac potassium and Febuxostat 2) Febuxostat and Ketorolac tromethamine 3) Febuxostat and Naproxen 4) Ibuprofen and Tramadol hydrochloride have been chosen for analytical study by stability indicting RP-HPLC and/or UV spectrophotometric methods. newlineTwo UV spectrophotometric methods viz .simultaneous equation method and first order derivative method and stability indicating RP-HPLC method have been developed and validated for combination (1) and (3). These methods (two UV and one stability RP-HPLC) of these two combinations were compared statistically by one-way ANOVA study with students t-test. Simple, accurate, precise, robust and reproducible stability indicating RP-HPLC method has been conducted for combined dosage form (2) and (4). Stability of all four pharmaceutical dosage forms was assessed in various degradation conditions like hydrolysis (acid- alkali), oxidation, thermal and photolytic conditions. newlineDoE (Design of Experiments) technique, an integral part of QbD has been applied to check the effect of different variables on acid degradation pattern of both the drugs via Full Factorial Design (FFD) 23(three factors at two levels) and kinetic study was also carried out to obtain degradation rate constant, half-life (t0.5), shelf life (t0.9), activation energy (Ea) and Arrhenius energy factor for both the drugs of combination (1). Moreover, same degraded samples were spiked into LC-MS/MS for analytical study. newlineThe calibration plots of all developed methods were linear over the selected concentration range with a correlation coefficient value nearer to 0.999. % assay values and % recoveries of drug of combined dosage forms were obtained within the limit specified in ICH guidelines i.e. 98-102%. One-way ANOVA study suggested stability indicating RP-HPLC method is more accurate and precise than UV spectrophotometric methods for combinat
Pagination: 
URI: http://hdl.handle.net/10603/242651
Appears in Departments:Pharmacy

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01_title.pdfAttached File279.37 kBAdobe PDFView/Open
02_declaration.pdf240.6 kBAdobe PDFView/Open
03_abstract.pdf249.18 kBAdobe PDFView/Open
03_certificate.pdf237.52 kBAdobe PDFView/Open
04_originality report certificate .pdf110.63 kBAdobe PDFView/Open
05_phd thesis non-exclusive license to gujarat technological university.pdf257.19 kBAdobe PDFView/Open
06_thesis approval form.pdf250.55 kBAdobe PDFView/Open
07_abstract.pdf249.01 kBAdobe PDFView/Open
08_acknowledgement.pdf278.27 kBAdobe PDFView/Open
09_contents.pdf411.57 kBAdobe PDFView/Open
10_abbreviations.pdf151.04 kBAdobe PDFView/Open
11_symbol.pdf245.16 kBAdobe PDFView/Open
12_list_of_figures.pdf335.62 kBAdobe PDFView/Open
13_list_of_tables.pdf477.5 kBAdobe PDFView/Open
14_chapter 1.pdf487.03 kBAdobe PDFView/Open
15_chapter 2.pdf686.04 kBAdobe PDFView/Open
16_chapter 3.pdf496.5 kBAdobe PDFView/Open
17_chapter 4.pdf485.13 kBAdobe PDFView/Open
18_chapter 5.pdf6.12 MBAdobe PDFView/Open
19_chapter 6.pdf524.55 kBAdobe PDFView/Open
20_references.pdf383.43 kBAdobe PDFView/Open
21_list_of_publications.pdf366.9 kBAdobe PDFView/Open


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