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Spectrophotometric and Chromatographic Methods for the Determination of a Binary Mixture of Sodium Cromoglicate and Xylometazoline Hydrochloride

Research Authors
Hayam M. Lotfy, Sarah S. Saleh, Nagiba Y. Hassan, Samia M. Elgizawy
Research Journal
ACAIJ
Research Rank
1
Research Vol
Vol. 13, No. 4
Research Year
2013
Research Member
Research Abstract

Simple, sensitive and precise spectrophotometric and chromatographic methods were developed for simultaneous determination of Sodium cromoglicate (SCG) and Xylometazoline hydrochloride (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 D1 of (XYLO) after prior separation of SCG from medium using 0.1 N HCl. The second method depends on derivative compensation ratio technique depending on the mean ratio of D1 peak amplitudes of SCG (D231.4 / D309.4). The chromatographic method utilized a Zorbax SB-C18 column and a mobile 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/min and 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.