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Method development and validation for separation of ten pharmaceutical raw materias using reversed- phase liquid chromatography and Drylab RTM simulation

Posted on:2017-07-25Degree:M.SType:Thesis
University:Northeastern Illinois UniversityCandidate:Alghareeb, RajwaFull Text:PDF
GTID:2471390017951678Subject:Chemistry
Abstract/Summary:
Ten pharmaceutical drugs were studied in this research, which are adenosine, Clonidine , Sumatriptan Succenate ,Ciprofloxacine HCl ,Levofloxacin, Fluconazole, Ketrolac trumethamine ,Pantoprazole sodium and Triprolidine HCl, Most of these drugs are used as antibiotics and relievers, and they are also used to treat different kinds of diseases such as constant and recurrent migraines.;A reversed phase liquid chromatography has been developed for separation of a mixture of these ten drugs. Agilent 1100 series High Performance Liquid Chromatography system with Diode Array Detector were used with Thermo BDS Hypersil C18 (250 X 4.6mm, 5 mum) column at a flow rate of 1.00 ml/min. The chromatographic conditions involved a detection wavelength at 270 nm, and mobile phase contains solvent A (25mM Potassium Phosphate Monobasic buffer pH 2.9) and solvent B (Acetonitrile). A linear gradient elution was chosen as the elution mode with 5-95 % gradient range.;Dry Lab software was used to simulate method development results. One parameter simulation was chosen to simulate optimum gradient time, pH, and solvent type. Then, two parameters simulation was used to simulate gradient time and ternary solvent. In addition to the above, three parameters simulation was tested including gradient time, temperature and ternary solvent. The develop method was validated in terms of robustness and considered as robust.
Keywords/Search Tags:Liquid chromatography, Method, Gradient time, Solvent, Phase, Simulation
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