HPLC法测定盐酸麻黄碱滴鼻液中盐酸麻黄碱的含量

目的本文尝试用不同的色谱条件测定盐酸麻黄碱滴鼻液中主药含量,通过比较其优劣,为麻黄碱的质量控制提供快速、有效的分析手段。方法选用依利特HYPERSIL BDS C18色谱柱(10μm,4.6mm×200mm),柱温为25℃,检测波长为257nm,进样量为20μL,流动相为20mmol/mL磷酸二氢钾(用磷酸调pH至6.0)-甲醇-三乙胺(50∶50∶0.2),流速为1.0 mmol/mL。结果该法室温条件下即能对盐酸麻黄碱进行有效分离和检测。方法线性范围:0.05~0.5 mg/mL(R2=0.9998)、平均回收率为98.4%、精密度为0.57%(n=9);20h内重复测定样品6次,结果无显著差异。结论选定方法的重现性、耐受性好,可作为测定盐酸麻黄碱滴鼻液中盐酸麻黄碱的含量测定方法。

HPLC Determination of Ephedrine Hydrochloride in the Ephedrine Hydrochloride Nasal Drops

Objective To develop a method for determination of the content of ephedrine hydrochloride in ephedrine hydrochloride nasal drops.Methods Chromatographic assay was performed on a column of HYPERSIL BOS C18(10μm,4.6mm×200mm),and mobile phase was20mmol/mL potassium dihydrogen phosphate solutions(adjust pH to 6.0 using phosphoric acid)—methanol—triethylamine(50∶50 ∶0.2),at a flow rate of 1.0 mL/min,the UV detection wavelength was 257nm,the column temperature was 25℃,and the injected volume was 20μL.Results The standard curve was linear in the range of 0.05~0.5 mg/mL and the multicorrelation coefficient was 0.9998.Conclusion The proposed method is simple,accurate,reliable and allows to be used as analytical method for the quality control of Ephedrine Hydrochloride nasal drops.