The Power of DryLab® Modeling Software in Method Development and Robustness Validation for Separation of Seven Pharmaceutical Active Ingredients Using Reversed-phase Liquid Chromatography

Download or read book The Power of DryLab® Modeling Software in Method Development and Robustness Validation for Separation of Seven Pharmaceutical Active Ingredients Using Reversed-phase Liquid Chromatography written by Ammar Albayati and published by . This book was released on 2017 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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 μm) and mobile phase containing solvent A (25mM Potassium Phosphate Monobasic buffer pH 2.5) and solvent B (Acetonitrile). DryLab® software simulation was also used for method development. Three parameters (3D) were tested including gradient time, buffer pH and temperature. Two DryLab® simulation were achieved, first with Acetonitrile ACN and second with Methanol MeOH. DryLab® method was found more time efficient and cost saving due to the following reasons: Only 18 runs (or less) was used in DryLab® software for simulation, while unlimited runs (at least 30) to develop a method in common wet chemistry lab. Planned conditions with HPLC runs for DryLab® software, while unplanned in wet chemistry lab. Achieve more than one simulation with DryLab® software (optimum condition), while only one optimum condition can achieve in common wet chemistry lab."--