HPLC method for simultaneous determination of metronidazole and preservatives in vaginal gel formulation

Abstract

A high-performance liquid chromatography (HPLC) method with ultraviolet (UV) detection for simultaneous determination of metronidazole, methylparaben, and propylparaben in vaginal gel formulation was described. The chromatography was carried out on a C18 (250 mm × 4.6 mm, 5 µm) column with acetonitrile and 0.3% phosphoric acid solution (20:80 v/v) modified by 0.1% triethylamine as mobile phase, at a flow rate of 1.0 mL min-1, with detection at 260 nm. Under these chromatographic conditions, the obtained retention times were approximately 3.43 min for metronidazole, 5.17 min for propylparaben, and 15.12 min for methylparaben. Analytical parameters specificity, linearity, accuracy, and precision were determined by validation procedure and found to be satisfactory. Overall, the proposed method was found to be simple, precise, and accurate for quality control of metronidazole in the presence of preservatives in gel formulation.