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Stability indicating spectrophotometric and chromatographic methods for the determination of azelastine hydrochloride in presence of its alkaline degradant

M.R.Elghobashy, U.M.Badran, M.Y.Salem, K.M.Kelani

Five simple, rapid and sensitive methods have been developed for the determination of azelastine hydrochloride in presence of its alkaline degradant. The first method utilizes first (D1) derivative spectrophotometry at 260 and 321 nm for the determination of azelastine hydrochloride without interference from its degradation product. The second method depends on the use of the first derivative of the ratio spectra (DD1) withmeasurement at 321 nm for determination of azelastine hydrochloride using the spectrum of 20 µg ml-1 (degradation) as a divisor. The third method is mean centering of ratio spectra withmeasurement at 306.4 nm.The fourthmethod depends on TLCdensitometry using acetonitrile: water: acetic acid (8:2:1, by volume) as a developing solvent, followed bymeasurement at 254 nm. The lastmethod is a reversed-phase liquid chromatography using 5mM ammonium acetate (pH 3.2): acetonitrile (40:60, v/v) as the mobile phase with UV detection at 253 nm. The suggested procedures were checked using laboratory prepared mixtures and were successfully applied for the analysis of its pharmaceutical preparations. The validity of the proposed methods was further assessed by applying the standard addition technique. The results obtained by applying the proposed methods were statistically analyzed and compared with the manufacturerÂ’s method.