Author(s): Ramchandra Krishna Pawar, Ram Lokhande, Ravi Yadav, Bhanupratap Bind, Shirish Velankar
A simple, specific and precise RP-HPLC method was developed and validated for determination of Assay for Nitrofurantoin Active Pharmaceutical ingredient (API). The method validation was performed as per ICH Q2 (R1) and FDA guidelines. The final chromatographic condition comprises of HPLC column i.e. Ascentis Express C18 (dimension 7.5cm x 4.6mm and particle size 2.7µm) and mobile phase containing a mixture of 0.1% Triethylamine pH-3.0 and Acetonitrile in the ratio of 80:20 v/v. The flow rate and column temperature were constantly maintained at 1.0 ml/min and at 30ºC respectively. The detection was performed at wavelength 254 nm using PDA detector. The retention time obtained for Nitrofurantoin peak was about 2.0 minutes. There was no interference due to the mobile phase or diluent was observed at retention time of Nitrofurantoin peak. Also, the data of linear regression analysis shows a linear relationship of Nitrofurantoin over the concentration range of 50-150μg/mL and the correlation coefficient value obtained was 0.9999. The Analytical method validation data shows that the method was Specific, Linear, Precise and Robust for the Assay determination of Nitrofurantoin API.