Abstract
Development and validation of the method for simultaneous determination of Benzydamine hydrochloride and methylparaben in dosage form by HPLC
Highlights
Benzydamine hydrochloride is a nonsteroidal, anti-inflammatory drug with local anesthetic and analgesic properties for pain relief, mouth and throat inflammations treatment [1]
Chemical structure of Benzydamine hydrochloride (Fig. 1) is N, N-dimethyl-3-[[1-(phenylmethyl)-1Hindazol-3-yl] oxy]-1-propanamine, i.e. it is a salt formed with a weak base and a strong acid; methylparaben (Fig. 2) is a methyl ester of parahydroxybenzoic acid
Benzydamine hydrochloride is protonated at pH 7.2 and less, and deprotonated – at pH 11.4 and higher
Summary
Benzydamine hydrochloride is a nonsteroidal, anti-inflammatory drug with local anesthetic and analgesic properties for pain relief, mouth and throat inflammations treatment [1]. Benzydamine hydrochloride quality requirements are given in the British Pharmacopoeia [2]. The British Pharmacopoeia describes Benzydamine hydrochloride quantitative determination by gas chromatography [3], with chloroform extraction using a non-polar phase (OV-17). In this case, simultaneous quantification of Benzydamine hydrochloride and methylparaben looks rather problematic due to prolonged and complicated sample preparation and related uncertainty of the final procedure. There are a number of articles describing the quantitative determination of Benzydamine hydrochloride in the finished dosage forms by HPLC [4,5,6]. Such approach is implemented because the HPLC mode of separation is the most efficient for the complex mixtures
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