Objective To establish the method for determining ephedrine hydochloride and pseudoephedrine hydrochloride in Keke Tablets by HPLC. Methods The samples were analyzed by a phemomenex Synergi Polar-RP column (4.6 mm×250 mm, 4 µm), with mobile phase methanol∶0.092%phosphoric acid (0.04%triethylamine and 0.02%second butylamine)=1.5∶98.5 at flow rate of 1.0 mL/min and detection at UV wavelength of 210 nm. The column temperature was 30 ℃. Results The linear ranges of ephedrine hydrochloride and pseudoephedrine hydrochloride were 6.51×10-3-0.651 µg (r=0.999 9) and 6.27×10-3-0.627 µg (r=1), respectively. The average recoveries (n=6) of ephedrine hydrochloride and pseudoephedrine hydrochloride were 102.26%and 103.71%, with RSD of 0.34%and 0.22%, respectively. Conclusion This method is simple, accurate, reproducible, highly specific and reliable results, and has the ability to effectively control the quality of alkaloids in Keke Tablets.%目的建立高效液相色谱法同时测定克咳片中盐酸麻黄碱、盐酸伪麻黄碱含量的方法。方法色谱柱：phenomenex Synergi Polar-RP柱(4.6 mm×250 mm,4µm)；流动相：甲醇∶0.092%磷酸溶液(含0.04%三乙胺和0.02%二正丁胺)＝1.5∶98.5；检测波长：210 nm；流速：1.0 mL/min；柱温：30℃。结果盐酸麻黄碱和盐酸伪麻黄碱的线性范围分别为6.51×10-3～0.651µg(r＝0.9999)、6.27×10-3～0.627µg(r＝1),平均加样回收率(n＝6)分别为102.26%、103.71%,RSD 分别为0.34%、0.22%。结论该方法简便、准确,重复性好,专属性高,结果可靠,可有效控制克咳片中生物碱成分的质量。
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