微乳液相色谱法测定非诺贝特自微乳化与脂质立方晶体系中非诺贝特的含量

Determination of fenofibrate in self-microemulsifying and lipid cubic crystalline delivery system with micro-emulsion liquid chromatography

目的建立自微乳化与脂质立方晶体系中非诺贝特含量测定的方法。方法采用微乳液相色谱法(MELC),色谱柱为Venusil ASB C8(4.6 mm×250 mm,5μm)柱;流动相为十二烷基硫酸钠(SDS)-正辛烷-正丁醇-H2O(质量比3.0∶0.6∶6.6∶89.8,用H3PO4调pH至2.5);检测波长为286 nm;流速为0.9mL/min;柱温为30℃。结果非诺贝特在50～150μg/mL范围内呈良好的线性关系(r=0.999 3);自微乳化与脂质立方晶体系中非诺贝特的平均加样回收率分别为100.49%和101.76%,RSD分别为1.7%和1.1%。自微乳化及脂质立方晶体系中非诺贝特的平均质量分数分别为48.4、11.6 mg/g。结论本方法准确度高、专属性强,可用于非诺贝特自微乳化与脂质立方晶制剂的质量控制。

Objective To establish a method for the determination of fenofibrate in self-microemulsifying and fenofibrate lipid cubic crystalline delivery system.Methods The MELC was performed on a Venusil ASB C8（4.6 mm×250 mm,5 μm） column with a flow rate of 0.9 mL/min,of which the mobile phase was SDS-octane-butanol-H2O（3.0∶0.6∶6.6∶89.8,adjusted to pH2.5 with H3PO4）.The detected wavelength was 286 nm and the column temperature was 30 ℃.Results The linear range of fenofibrate was 50-150 μg/mL（r=0.999 3）.The average recovery ratio of two preparations were 100.49% and 101.76%,and RSD were 1.7%,1.1%,respectively.The contents of fenofibrate in self-microemulsifying preparation and lipid cubic crystalline were 48.4,11.6 mg/g,respectively.Conclusion This method is accurate and specific for the quality control of fenofibrate in self-microemulsifying preparation and lipid cubic crystalline.