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目的建立用反相高效液相色谱法测定小儿清热止咳颗粒中盐酸麻黄碱和盐酸伪麻黄碱含量的方法。方法采用ZORBAXSBC18色谱柱,流动相为0.1%磷酸溶液-乙腈(96∶4),流速为1.0mL·min-1,紫外检测波长为205nm。结果盐酸麻黄碱线性范围为4.388～43.88μg·mL-1(r=0.9999),平均回收率99.7%,RSD为2.1%(n=6)。盐酸伪麻黄碱线性范围为5.300～53.00μg·mL-1(r=0.9997),平均回收率98.5%,RSD为2.8%(n=6)。结论本法定量准确、重复性好,可作为该制剂的质量控制方法。
Objective To establish a method for the determination of ephedrine hydrochloride and pseudoephedrine hydrochloride in children Qingre Zhi Zhi Ke particles by reversed-phase high performance liquid chromatography. Methods The mobile phase consisted of 0.1% phosphoric acid solution (96: 4), the flow rate was 1.0 mL · min-1 and the UV detection wavelength was 205 nm using ZORBAXSBC18 column. Results The linear range of ephedrine hydrochloride was 4.388 ~ 43.88μg · mL-1 (r = 0.9999), with an average recovery of 99.7% and a RSD of 2.1% (n = 6). The linear range of pseudoephedrine hydrochloride was 5.300-53.00μg · mL-1 (r = 0.9997), with an average recovery of 98.5% and a RSD of 2.8% (n = 6). Conclusion This method is accurate and reproducible, and can be used as a quality control method for this preparation.