Abstract
A rapid, highly sensitive, accurate, precise and validated RP- HPLC method was developed for the simultaneous determination of Acetaminophen (ACT) and Guiafenesin (GFN) in pharmaceutical dosage form as per ICH guidelines. The mobile phase consisted of water, methanol and glacial acetic acid (60:40;1.5 % v/v) operated on isocratic mode. The flow rate of the mobile phase was 1.0 mL/minute. Chromatographic separation of acetaminophen and Guiafenesin was performed on Inertsil C18 column ( 250 x 4.6 mm, 5µm). The injection volume was 10 µL. The retention time of ACT and GFN were 4.04 and 9.6 minutes respectively and the total run time of the analysis was 15 minutes. The developed method was validated for parameters such as accuracy, precision, linearity and solution stability. The proposed method had been successfully used for the estimation of the drugs in tablet dosage form. The intraday and inter day precision was found to be within the limits. Conclusion: In this research project we have reported a stability indicating RP HPLC method for the development as well as validation for the simultaneous estimation of ACT and GFN in combined dosage form using simple mobile phase. The sample recoveries in formulation were in good agreement with their respective label claims and they suggested non- interference of formulation excipients in the determination.
