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目的:建立黄芩素静脉注射亚微乳剂中黄芩素含量测定的高效液相色谱法。方法:采用化学破乳法,以无水乙醇为破乳剂破坏乳剂界面性质,制备供试品溶液;以kromasil(C18(5μm,4.6mm×250mm)为色谱柱,甲醇-0.05%磷酸(65∶35)为流动相,流速1.0mL·min-1,检测波长275nm,外标法测定。结果:乳剂中加入50倍无水乙醇可获得澄清透明的供试品溶液;在1.2～48.0μg·mL-1浓度范围内,峰面积与黄芩素浓度的线性方程为A=56.23C-2.703,r=0.9999;低、中、高浓度连续进样的RSD分别为1.1%,0.23%,0.10%;8h内样品溶液稳定,样品重复测定的RSD为1.2%;平均回收率为100.7%(n=9)。结论:无水乙醇具有良好的破乳效果,空白乳剂对测定无干扰,方法简便、准确,能够满足黄芩素亚微乳剂中黄芩素含量测定的要求。
Objective: To establish a HPLC method for the determination of baicalein in intravenous injection of baicalein submicroemulsion. Methods: The chemical emulsion breaking method and anhydrous ethanol as the demulsifier were used to destroy the interfacial properties of emulsions. The preparation of the test solution was as follows: Kromasil (C18 (5μm, 4.6mm × 250mm) 35) as the mobile phase, the flow rate was 1.0 mL · min-1, the detection wavelength was 275 nm, and the external standard method was used.Results: The clear and transparent sample solution was obtained by adding 50 times of absolute ethanol to the emulsion; -1, the linear equation of peak area and baicalein concentration was A = 56.23C-2.703, r = 0.9999. The RSDs of low, medium and high concentration continuous injection were 1.1%, 0.23% and 0.10% The RSD was 1.2% and the average recovery was 100.7% (n = 9) .Conclusion: Absolute ethanol has a good demulsification effect, the blank emulsion has no interference on the determination, the method is simple and accurate, To meet the baicalein submicron emulsion baicalein content determination requirements.