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The Power of DryLabRTM Modeling Software in Method Development and Robustness Validation for Separation of Seven Pharmaceutical Active Ingredients Using Reversed-Phase Liquid Chromatograph

Posted on:2018-02-24Degree:M.SType:Thesis
University:Northeastern Illinois UniversityCandidate:Albayati, AmmarFull Text:PDF
GTID:2471390020957459Subject:Chemistry
Abstract/Summary:
Nine randomly selected pharmaceutical products, which included Ranolazine, Theophylline Anhydrous, Lidocaine, Ropivacaine Hydrochloride, Pheniramine Maleate, Chlordiazepoxide and Ondansetron Hydrochloride. Most of these products are often used as non-opioid analgesics for treatment of migraines.;A reversed phase liquid chromatography had been developed in wet chemistry lab for separation of a mixture of these products by using Agilent 1100 series High Performance Liquid Chromatography (HPLC) system, Diode Array Detector (DAD), Waters C18 column (250 X 4.6mm, 5 microm) and mobile phase containing solvent A (25mM Potassium Phosphate Monobasic buffer pH 2.5) and solvent B (Acetonitrile).;DryLabRTM software simulation was also used for method development. Three parameters (3D) were tested including gradient time, buffer pH and temperature. Two DryLabRTM simulation were achieved, first with Acetonitrile ACN and second with Methanol MeOH. DryLabRTM method was found more time efficient and cost saving due to the following reasons: • Only 18 runs (or less) was used in DryLabRTM software for simulation, while unlimited runs (at least 30) to develop a method in common wet chemistry lab. • Planned conditions with HPLC runs for DryLabRTM software, while unplanned in wet chemistry lab. • Achieve more than one simulation with DryLabRTM software (optimum condition), while only one optimum condition can achieve in common wet chemistry lab.
Keywords/Search Tags:Drylabrtm, Software, Wet chemistry lab, Method, Liquid, Simulation
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