Method Development and Validation For Separation of Eight Pharmaceutical Active Ingredients Using Reversed- Phase Liquid Chromatography and Drylab RTM Modeling.

摘要

A reversed-phase HPLC method was developed to separate a mixture of eight pharmaceutical drug substances which included Lidocaine, Meclizine, Ciprofloxacin HCl, Ropivacain HCl, Adifovire dipivoxil, Doxipin HCl, Thiocolchicoside and Trazodone HCl. These drugs are used a local anesthetic, an antihistamine, antimicrobial agent, for to treat Chronic Hepatitis B infection, depression, anxiety, insomnia, and for muscle relaxation.;Agilent 1260 infinity HPLC system with Diode Array Detector was used with Waters C18 (250 x 4.6mm, 5 mum) column with mobile phase as solvent A which is 25mM Potassium Phosphate Monobasic buffer with pH 2.5 and solvent B which is 20% methanol and 80%acetonitrile mixture.;DryLabRTM software with 3D modeling involving gradient time, column temperature and proportion of methanol to acetonitrile simulated optimum segmented gradient of 12% organic solvent at time zero which gradually increased to 18% in 11 minutes and then sharply increased to 90% in 9 minutes. Solvent strength remained at 90% for 3 minutes and was sharply reduced to 12% in 30 seconds. The method was developed under the following chromatographic conditions: buffer pH at 2.5, column temperature at 56 °C, flow rate of 1.00 ml/min and detection wavelength at 235 nm. For validation of developed method robustness was studied and developed method considered as robust.