Original Articles
Amit Kumar De1, Ashok Kumar Be
Abstract
A simple, accurate, precise, reproducible and selective chromatographic technique for the estimation of metronidazole from bulk and tablet dosage form has been described in this study. The chromatographic technique was developed using a C18 column and a mobile phase consisting of phosphate buffer of pH 3.5 and acetonitrile in ratio 60:40 and at a flow rate 1.0 ml.min-1. The method was validated as per ICH Q2 guidelines on the basis of accuracy, precession, linearity, ruggedness, robustness and selectivity. The method was found to be linear in the concentration range 10.56 to 80.74 μg/ml (r2 = 0.999) and limit of quantisation 5.28 μg/ml. A recovery of 99.88% was observed for the method with sufficient precession and reproducibility. The results of the described RP-HPLC method therefore present successful application of this method for routine quality control analysis of metronidazole in marketed formulations.