A novel stability indicating RP-HPLC method development and validation forsimultaneous estimation of phenylephrine, acetaminophen, guaifenesin anddextromethorphan in tablet dosage form

摘要

A novel simple, sensitive, accurate and precise RP-High Performance Liquid Chromatography (HPLC) method for the simultaneous estimation of Phenylephrine (PHE), Acetaminophen (ACE), Guaifenesin (GUA) and Dextromethorphan (DEX) combined dosage form has been developed and validated. The components were well separated using Altima, 150 x 4.6 mm, 5m column with 1ml of Conc. Orthophosphoric acid in a 1000ml of water as Solvent A and Acetonitrile as Solvent B at a flow rate of 1.0 mL/min by using gradient programme. The eluents were detected at 272 nm using UV detector. The retention time of PHE, ACE, GUA and DEX found to be 2.5, 6.1, 8.3 and 9.0 min respectively. The linearity was observed between 2.0-7.0μg/mL,130-455μg/mL, 50-300μg/mL and 2.5-15 μg/mL for Phenylephrine, Acetaminophen, Guaifenesin and Dextromethorphan respectively. The method was validated for system suitability, specificity, linearity, accuracy, precision, ruggedness and robustness as per ICH guidelines and the results were found to be within the limits. The developed method was used for the stability studies and for the routine quality control testing of PHE, ACE, GUA and DEX combined dosage form.