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目的建立咳喘清片中盐酸麻黄碱和盐酸伪麻黄碱的同时测定方法。方法采用高效液相色谱法,色谱柱为DIONEX Acclaim(C18(250mm×4.6mm,5μm,Dionex Bonded Silica Products);柱温:40℃;流动相为0.02mol/L磷酸二氢钾溶液(磷酸调节pH值至2.7)-乙腈(97:3,含0.1%三乙胺);体积流量:1.3mL/min;检测波长:210nm;进样量:20μL。结果盐酸麻黄碱在13.0～201.0μg/mL(r=0.9999),盐酸伪麻黄碱在6.2～98.5μg/mL(r=0.9999)线性关系均良好,回收率RSD均小于5%。结论该方法准确、稳定、可靠,更好地用于咳喘清片中盐酸麻黄碱和盐酸伪麻黄碱的质量控制。
Objective To establish a method for simultaneous determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in Kechuan Qingpian Tablet. Methods The column was DIONEX Acclaim (C18 (250mm × 4.6mm, 5μm, Dionex Bonded Silica Products); the column temperature was 40 ℃; the mobile phase consisted of 0.02mol / L potassium dihydrogen phosphate solution pH = 2.7) -acetonitrile (97: 3 with 0.1% triethylamine); volume flow rate: 1.3 mL / min; detection wavelength: 210 nm; injection volume: 20 μL.RESULTS Ephedrine hydrochloride was in the range of 13.0 ~ 201.0 μg / mL (r = 0.9999) and pseudoephedrine hydrochloride in the range of 6.2 ~ 98.5μg / mL (r = 0.9999), the RSDs of recoveries were all less than 5% .Conclusion The method is accurate, stable and reliable and can be used to treat cough and asthma Quality Control of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride Tablets.