Method Development and Validation for Separation of Eight Pharmaceutical Raw Materials Using Reversed-phase Liquid Chromatography and Drylab® Simulation

Download or read book Method Development and Validation for Separation of Eight Pharmaceutical Raw Materials Using Reversed-phase Liquid Chromatography and Drylab® Simulation written by Elham Saleh Alshaikh and published by . This book was released on 2017 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: "A reversed-phase HPLC method was developed to separate a mixture of eight pharmaceutical active ingredients: Theophline, Lidocaine, pheniramine, Ondanstron HCl, Triprolidine, Chloridiazepoxide and Doxepin HCl.These drugs are used as antibiotics and relievers and some are used to treat different kinds of diseases such as constant and recurrent migraines. Agilent 1100 series system with Diode Array Detector was used with Waters C18 (250 X 4.6mm, 5 μm) column and mobile phase consisted of solvent A (25mM Sodium acetate buffer at pH4) and solvent B (17% Acetonitrile). DryLab® software with 3D modeling which involved gradient time, column temperature and different proportions of acetonitrile resulted in an optimum linear gradient of 17% organic solvent at zero time which slowly increased to 35% in 22 minutes. Solvent Strength was controlled at 50% for 3 minutes and decreased to 17% in 3 seconds. Buffer was chosen at pH4 with column temperature at 53°C, flow rate of 1.00 mL/min and detection wavelength at 270 nm. The developed method was validated in terms of robustness and considered robust."--