Stability Indicating Liquid Chromatographic Method for Estimation of Xylometazoline Hydrochloride in Pharmaceutical Dosage Form

Abstract

A simple, specific, precise, and accurate RP-HPLC method has been developed and validated for Xylometazoline Hydrochloride. The mobile phase has been used for separation consisting of buffer (Acetate buffer in water, pH adjusted to 5 with triethyl amine)-Acetonitrile (30: 70, v/v) using phenomenax C18 column with flow rate 1.0 ml/min. Detection wavelength was 240 nm. The method has been linear for the range of 1 – 300 μg/mL with r2 0.999. Drug has been shows 99 to 101% recovery. ICH Q2R1 guideline has been used for validation of developed analytical method. Drug was exposing to forced degradation condition like hydrolysis, oxidation, thermal and photolytic. Method can well resolve all degraded product as compare to Xylometazoline. The isolate alkali degraded product was characterized by NMR, MASS and IR data. Developed method can routinely used for the estimation of Xylometazoline drug from the dosage form and also for stability sample. Keywords: Xylometazoline, HPLC, Stability Indicating method, Acidic, Basic and Water degraded products, pharmaceutical dosage form