HPLC法测定黄芩素静脉注射亚微乳剂的含量

HPLC determination of baicalein submicron emulsion for injection

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 an RP-HPLC method for the determination of baicalein in its submicron for injection.Methods：The analysis was carried on a kromasil C18（5 μm,4.6 mm × 250 mm） column,using methanol-0.05%phosphoric acid（65∶35）as the mobile phase.The detection wavelength was set at 275nm and flow rate was 1.0 mL·min-1.Results：The assay displayed good linearity over the range of 1.2-48 μg·mL-1 and the regression equation obtained was A=56.233C-2.703（r=0.9999）.The precisions（RSD）of the three concentrations（high,medium and low）of baicalein standard solutions were 1.11%,0.23%,0.10%,respectively.Baicalein was stable in the prepared samples after placing in the auto-sampler for 8h at ambient temperature.The repetition RSD of baicalein was 1.2%.The average recovery was 100.7%（n=9）.Conclusion：The method is simple,accurate and suitable for the content determination of baicalein in its submicron emulsion for injection.