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目的:建立高效液相色谱法测定复方吴茱萸碱纳米乳制剂中吴茱萸碱的含量。方法:通过有机溶剂法破乳,采用高效液相色谱法在225 nm波长处测定峰面积,测定复方吴茱萸碱纳米乳中吴茱萸碱的含量。结果:吴茱萸碱在1.25～10μg.mL-1范围内与峰面积呈良好的线性关系;回归方程为A=122 583C-33 922(r=0.999 7);平均回收率为99.96%,RSD为0.31%(n=9);日内及日间精密度的RSD均小于1%(n=5)。结论:建立的高效液相色谱法准确度高、专属性好,可用于吴茱萸碱复方纳米乳中吴茱萸碱的含量测定。
Objective: To establish an HPLC method for the determination of evodiamine in compound evodiamine nanoemulsion. Methods: The organic solvent method was used for demulsification. The peak area was determined by HPLC at 225 nm. The content of evodiamine in the compound evodiamine nanoemulsion was determined. Results: The evodiamine showed a good linear relationship with the peak area in the range of 1.25-10μg.mL-1. The regression equation was A = 122 583C-33 922 (r = 0.999 7). The average recovery was 99.96% and the RSD was 0.31 % (n = 9). The intra-day and inter-day RSDs were less than 1% (n = 5). Conclusion: The established HPLC has high accuracy and specificity, and can be used for the determination of evodiamine in evodiamine compound nanoemulsion.