Method Development and Validation for Separation of Eight Pharmaceutical Active Ingredients Using RP-HPLC Method and Drylab® Modeling

Download or read book Method Development and Validation for Separation of Eight Pharmaceutical Active Ingredients Using RP-HPLC Method and Drylab® Modeling written by Anamika Das and published by . This book was released on 2017 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In this research, 8 pharmaceutical drugs were studied including Nifedipine, Oxcarbazepine, Ticagrelor, Elvitegravir, Metoclopramide HCl, Ciprofloxacin HCl, Levofloxacin hemihydrates and Vanillin. Most of these drugs are used as antibiotics and relievers to treat various kinds of diseases such as high blood pressure, chest pain, stroke, heart attack, stomach discomfort and epilepsy seizures. Moreover, one drug is used in the food industry as flavoring. A reversed-phase HPLC method has been developed to separate a mixture of eight pharmaceutical active ingredients and identify them. Aligent 1100 series HPLC system with Diode Array Detector was used with Xterra C18 (250 X 4.6 mm, 5 μm) column made by Waters with a flow rate of 1.0 ml/min. The column temperature was controlled at 55 °C and the detection wavelength was set at 250 nm. A mobile phase consisted of solvent A (25 mM Potassium Phosphate Dibasic buffer at pH 6.57) and solvent B (100% Acetonitrile). DryLab® software with 2D modeling was used to simulate method development results. First, one parameter was chosen such as gradient time, pH and solvent type. Second, two parameters were used such as simulation of gradient time, temperature and ternary solvent to find the optimum segmented gradient of 5.45% organic solvent at time zero which slowly increased to 25.5% in 11 minute and sharply to 78% in 34 minute. Solvent strength was sharply reduced to 5.45% in 30 seconds. The develop RP-HPLC method was validated in terms of robustness and considered as robust."--