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Spectrophotometric and chromatographic methods for the determination of a binary mixture of sodium cromoglicate and xylometazoline hydrochloride

Hayam M.Lotfy, Sarah S.Saleh, Nagiba Y.Hassan, Samia M.Elgizawy

Simple, sensitive and precise spectrophotometric and chromatographic methods were developed for simultaneous determination of Sodium cromoglicate (SCG) andXylometazolinehydrochloride(XYLO) in their pure form and nasal solution. By applying the spectrophotometric methods, (SCG) was determined by direct spectrophotometry through measuring its zero-order (D0) absorption spectra at 325 nm;while (XYLO)was determined using two methods. The first method utilized the first derivative spectra D1of (XYLO) after prior separation of SCG frommediumusing 0.1 N HCl. The second method depends on derivative compensation ratio technique depending on the mean ratio of D1 peak amplitudes of SCG (D 231.4 / D 309.4). The chromatographicmethod utilized aZorbax SB-C18 column and amobile phase of acetonitrile: 10 mM phosphate buffer (pH 4): triethylamine, in ratio (80: 19.9: 0.1 v/v/v), delivered at flow rate of 1.2 mL/minand the detections were done at 220 nm. The proposed methods were validated in compliance with the ICH guidelines and were successfully applied for the analysis of (SCG) and (XYLO) in the laboratory prepared mixtures and combined pharmaceutical dosage form.