Development and validation of the method for simultaneous determination of benzydamine hydrochloride and methylparaben in dosage form by HPLC

Abstract

The aim. The aim of the current work was to develop and validate HPLC method for simultaneous determination of Benzydamine hydrochloride (API) and methylparaben (preservative) in the dosage form containing Benzydamine hydrochloride as an active pharmaceutical ingredient. Methods. The separation was performed on Grace Altima C18 column (250 mm * 4.6 mm, particle size 5 microns). The mobile phase consisted of 3.0 g of sodium perchlorate, 1 ml of trimethylamine and was adjusted to pH 3 with perchloric acid. The flow rate of mobile phase was 1 ml/min, detection wavelength was 320 nm for Benzydamine hydrochloride and 254 nm for Methylparaben. Results. The method was validated according to ICH Q2 requirements and found to be robust, specific, linear in the range of 80–120 % for the analytes. The maximum RSD for each compound was less than 1.3 %. The accuracy of the method was within the acceptance criteria. Conclusions. The method for simultaneous determination of Benzydamine hydrochloride and methylparaben was developed and validated according to the International Conference on Harmonization requirements. All validation parameters matched the acceptance criteria of the guideline. The developed method can be applied in routine control in QC laboratories for simultaneous determination of Benzydamine hydrochloride and Methylparaben in Benzydamine dosage forms.