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1 2015

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Development micellar HPLC method for simultaneous determination of ephedrine, pseudoephedrine, and methylephedrine in Ephedra Herb and traditional Chinese medicinal preparations

Dong Y. M., An Q., Lu N. W., Li N.

Acta Chromatographica

2015

Vol. 27, no. 2

355--372

A micellar high-performance liquid chromatography (HPLC) method has been described for simultaneous determination of ephedrine, pseudoephedrine, and methylephedrine in Ephedra Herb and two traditional Chinese preparations. The separation and determination of ephedrine, pseudoephedrine, and methylephedrine were performed using a mobile phase containing 1.75 × 10−1 mol•L−1 sodium dodecyl sulphate and 0.02 mol•L−1 potassium hydrogen phosphate with 10% (v/v) methanol at pH 3.0, running at 1.5 mL•min−1 by a Venusil XBP C18 (250 × 4.6 mm, 5 μm) column at 40 °C. The detected wavelength was set at 210 nm. The method was validated according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines. The main analytical parameters were linearity (r > 0.9990), intra- and inter-day precisions (relative standard deviation [RSD %], 0.33–1.63, and RSD %, 1.26–2.20, respectively), limit of quantifications [LOQs], and limit of detections [LODs] (2.6 × 10−4 and 7.8 × 10−5 mg•mL−1 for ephedrine, 6.8 × 10−4 and 2.0 × 10−4 mg•mL−1 for pseudoephedrine, and 5.0 × 10−4 and 1.5 × 10−4 mg•mL−1 for methylephedrine). RSDs of recoveries were <5.5% in the three samples. Based on the optimized chromatographic conditions and the eluted orders, a model of separation mechanism for the analytes was established. The results indicated that the proposed method was an accurate, “green” and cheap method.