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目的:建立肺炎合剂中盐酸麻黄碱的鉴别和含量测定方法。方法:(1)薄层鉴别:溶液取5μL,使用硅胶G薄层板,展开剂为正丁醇-冰醋酸-水(8∶2∶1),显色剂为茚三酮试液,在105℃下加热显色。(2)含量测定:色谱柱为Capcell PAK C18(150 mm×4.6 mm,5μm),流动相为乙腈:0.1%磷酸(含三乙胺0.1%)(6∶94),检测波长为210 nm,流速为0.9 m L·min-1,柱温30℃,进样量为10μL。结果:(1)供试品色谱中,在与对照品色谱相应的位置上,显相同的红色斑点。(2)盐酸麻黄碱在0.42~2.12μg范围内,线性范围良好(r=0.9999),平均回收率为98.12%,RSD为1.10%(n=6)。结论:薄层色谱法可以用于肺炎合剂中盐酸麻黄碱的鉴别。高效液相色谱法简便、准确、灵敏度高,重复性好,可用于肺炎合剂中盐酸麻黄碱的含量测定。
Objective: To establish the method for the identification and content determination of ephedrine hydrochloride in Pneumonia Mixture. Methods: (1) TLC identification: take 5μL solution, using silica gel G plate, developing solvent is n-butanol-glacial acetic acid-water 105 ℃ heating color. (2) Assay: The chromatographic column was Capcell PAK C18 (150 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile 0.1% phosphoric acid with triethylamine 0.1% (6:94), the detection wavelength was 210 nm, The flow rate was 0.9 m L · min-1, the column temperature was 30 ℃ and the injection volume was 10μL. Results: (1) for the test product chromatography, chromatography with the reference substance corresponding position, showed the same red spots. (2) Ephedrine hydrochloride showed a good linearity (r = 0.9999) in the range of 0.42-2.12 μg with an average recovery of 98.12% and a RSD of 1.10% (n = 6). Conclusion: TLC can be used for the identification of ephedrine hydrochloride in Pneumonia Mixture. High performance liquid chromatography is simple, accurate, sensitive, reproducible, and can be used for determination of ephedrine hydrochloride in pneumonia mixture.