Development and validation of a RP–HPLC method for the quantization studies of metronidazole in tablets and powders dosage forms

Abstract

An isocratic high-performance liquid chromatography (HPLC) procedure was developed for the quantitative determination of metronidazole in tablets and powders. HPLC separation was carried out by reversed phasechromatography on Kromasil C18 (250 mm x 4.6 mm i.e.; 5 ìm particle size), held in thermostat at 25°C. The mobile phase consisted of methanol/ 0.1% phosphoric acid aq. (20/80v/v), with a flow rate of 1 ml/min and with UV detection at 317 nm. In order to validate the method, the following parameters have been investigated: linearity (r2=0.9999), range, precision, accuracy, specificity, limit of detection and limit of quantification. The described method can be successfully applied for the analysis of the active pharmaceuticalcompound in tablets and powders. This paper aimed to develop and validate an HPLC sensitive applicable method to determine the quantity of metronidazole in tablets and powders, contributing to the quality and safety control of these types of pharmaceutical preparations