Green microemulsion electrokinetic chromatographic method for simultaneous determination of azelastine and budesonide

Abstract

A facile, sensitive, and eco-friendly microemulsion electrokinetic chromatographic method coupled with field amplified sample stacking was developed for the simultaneous determination of azelastine (AZL) and budesonide (BUD) in their combined pharmaceutical preparations. The separation of both drugs was achieved using 13 mM borate buffer (pH 9.0) containing 1.2% sodium dodecyl sulphate (SDS), 2.4% n-butanol, and 1.0% ethyl acetate as the background electrolyte (BGE). A capillary tube (40 cm effective length; 75 μm internal diameter) of uncoated fused silica was used for separation of the studied analytes. A diode array detector was used to monitor the studied compounds at 195 nm. The applied voltage and temperature were adjusted at 28 kV and 25 °C, respectively. The method was linear over the concentration ranges of 0.5–50.0 μg/mL for azelastine and 1.0–20.0 μg/mL for budesonide. The sensitivity was improved by more than 10 folds by using field amplified sample stacking technique. Moreover, the method was applied for separation of budesonide epimers (22R-BUD and 22S-BUD) by increasing the concentration of SDS in the BGE to be 1.8%. Greenness evaluation was performed using analytical eco-scale, Green Analytical Procedure Index (GAPI) and Analytical GREEnness (AGREE) approaches. The excellent green profile of the developed method, confirmed by the three approaches, has supported its applicability in quality control laboratories.