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目的建立测试咳尔康口服液中盐酸麻黄碱含量的高效液相方法,并对此方法进行系统的方法学验证,以确保应用该方法测试的结果准确、可靠。方法采用色谱柱:AgilentTC-C18柱(4.6×250mm,5μm,Agilent,美国),流动相:甲醇-0.02mol/L磷酸二氢钾溶液(以磷酸调至PH2.5)(5:95),检测波长为210nm。结果盐酸麻黄碱在2.048mgL-～500mgL-1范围内线性关系良好,得到线性回归方程为Y=1.0818X+0.0011,相关系数为0.9993(n=7);低、中、高浓度的精密度RSD值分别为0.27%、0.76%、0.53%;重复性RSD为0.67%;平均加样回收率为99.31%,RSD为0.90%;供试品溶液室温放置8h稳定。结论本方法测定咳尔康口服液盐酸麻黄碱的含量准确、可靠,操作简单、用时短,可用于咳尔康口服液中盐酸麻黄碱的含量测定。
Objective To establish a HPLC method for the determination of ephedrine hydrochloride in Ke’erkang Oral Liquid. The method was systematically verified by methodology to ensure that the results of this method were accurate and reliable. Methods The mobile phase consisted of methanol-0.02 mol / L potassium dihydrogen phosphate (adjusted to pH 2.5 with phosphoric acid) (5:95) on a AgilentTC-C18 column (4.6 × 250 mm, 5 μm, Agilent, The detection wavelength is 210nm. Results The linear regression equation of ephedrine hydrochloride was 2.048mgL- ~ 500mgL-1, and the linear regression equation was Y = 1.0818X + 0.0011 with a correlation coefficient of 0.9993 (n = 7). The RSDs of low, medium and high concentrations The values were 0.27%, 0.76% and 0.53% respectively. The repeatability RSD was 0.67%. The average recovery was 99.31% and the RSD was 0.90%. The test solution was stable at room temperature for 8 hours. Conclusion The method for determination of Ke Er Kang oral ephedrine hydrochloride content is accurate, reliable, simple operation, with a short time, can be used for the determination of content of ephedrine hydrochloride in Ke Er Kang oral solution.