小儿咳喘灵颗粒中盐酸麻黄碱含量测定的2种HPLC法比较

Determination of Ephedrine Hydrochloride in Xiaoerkechuanling Granules by Two Different HPLC Methods:A Contrastive Analysis

目的:比较测定小儿咳喘灵颗粒中盐酸麻黄碱含量的2种高效液相色谱(HPLC)法。方法:(1)法色谱条件:色谱柱为Phenomenex C18(250mm×4.6mm,5μm),流动相为甲醇-水(1:1),检测波长为254nm;(2)法色谱条件:色谱柱为Phenomenex C18(250mm×4.6mm,5μm),流动相为乙腈-磷酸溶液(内含0.02mol.L-1磷酸二氢钾、0.01mol.L-1磷酸)=5:95,检测波长为210nm。结果:(1)法盐酸麻黄碱的检测浓度在0.08～40μg.mL-1范围内与峰面积积分值呈良好的线性关系(r=0.9999),平均回收率为101.72%,RSD=2.77%;(2)法盐酸麻黄碱的检测浓度在0.4～400μg.mL-1范围内与峰面积积分值呈良好的线性关系(r=1.0000),平均回收率为99.60%,RSD=2.91%。结论:2种HPLC法结果均准确,专属性、重现性均好,但(1)法提取更完全,未使用有机溶剂,操作性更强。

OBJECTIVE： To determine the content of Ephedrine hydrochloride in Xiaoerkechuanling granules by two HPLC methods. METHODS：The chromatographic conditions for the first HPLC method were as follows：the phenomenex C18 column（250mm×4.6mm,5μm） was used with methanol- water（1 ： 1） as mobile phase at a detection wavelength of 254 nm; the chromatographic conditions for the second HPLC method were as follows：the phenomenex C18 column（250mm×4.6mm,5μm） was used with acetonitrile- phosphoric acid solution（contain 0.02 mol · L^- 1 potassium dihydrogen phosphate and 0.01 mol · L^-1 phosphoric acid）（5 ： 95） as mobile phase at a detection wavelength of 210 nm.RESULTS：By HPLC method one, the linear range of Ephedrine hydrochloride was 0.08 μg· mL^ -1 40 μg· mL^ -1（r = 0. 999 9）with the average recovery at 101.72% and the RSD at 2.77% ; by the second HPLC method, the linear range of Ephedrine hydrochloride was 0.4 μg · mL^ -1-400 μg· mL^ -1（r = 1.000 0） with the average recovery at 99.60% and the RSD at 2.91% .CONCLUSION： Both of the two HPLC methods are accurate, specific and reproducible, but by the first HPLC method, the extraction was more complete and more operable, and no organic solvent was used.