Method Development and Validation for Separation of Nine Pharmaceutical Active Ingredients Using Reversed-phase Liquid Chromatography and DryLab® Modeling Software

Download or read book Method Development and Validation for Separation of Nine Pharmaceutical Active Ingredients Using Reversed-phase Liquid Chromatography and DryLab® Modeling Software written by Lena Ghadimipour and published by . This book was released on 2018 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: "A reversed-phase HPLC method was developed to separate a mixture of nine pharmaceutical active ingredients: Ciprofloxacin Hydrochloride, Gatifloxacin Hydrochloride, Levofloxacin Hemihydrate, Metoclopramide Hydrochloride, Pheniramine Maleate, Ropivacaine Hydrochloride, Theophylline Anhydrous, Thiocolchicoside, Trazodone Hydrochloride. 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 C8 (250 X 4.6mm, 5μm) column and mobile phase consisted of solvent A (25mM Potassium Phosphate Dibasic buffer at pH 7) and solvent B (8.4% Acetonitrile). DryLab® software with 3D modeling which involved gradient time, column temperature and different proportions of acetonitrile resulted in an optimum linear gradient of 8.4% organic solvent at zero time which slowly increased to 20.4% and 95% in 17.5 and 25 minute. Then, solvent Strength was controlled at 95% for 5 minute. Buffer was chosen at pH 7 with column temperature at 34oC, flow rate of 1.00 mL/min and detection wavelength at 220 nm. The developed method was validated in terms of robustness and considered robust."--