HPLC法测定纳米乳中羟喜树碱的含量和有关物质

HPLC determination of hydroxycamptothecin and its selated substances in its nano-emulsions

目的:采用高效液相色谱法测定纳米乳中羟喜树碱的含量。方法:运用强碱破乳有机溶剂萃取法除去纳米乳中的脂质,甲醇定容后高效液相色谱法测定纳米乳中羟喜树碱的含量。色谱条件为:以 Kromasil(250mm×4.6mm,5μm)为色谱柱,甲醇-水(60:40)为流动相,流速1mL·min^(-1),检测波长分别为254nm(检测有关物质)和266nm(含量测定),柱温35℃。结果:羟喜树碱纳米乳中其他物质对药物的测定无干扰,在2～20μg·mL^(-1)范围内线性关系良好,平均回收率为99.8%,重复性和稳定性良好。结论:本方法除去了纳米乳中的脂质,保护了色谱柱,适于羟喜树碱纳米乳注射液的质量控制。

Objective：To develop HPLC method for the determination of hydroxycamptothecin （HCPT） in its nano - emulsions. Methods： Oil phase and other lipid components in the nano - emulsions were treated with 0. 1mol · L^-1 NaOH ,followed by extraction with chloroform. The measurement condition used are as follows：Kromasil column （250 mm×4.6mm,5μm） ; mobile phase ： methanol - water （ 60： 40 ） ; flow rate ： 1 mL ·min^-1 ; wavelength for measurement：254 nm （determination of related substances） and 266 nm （determination of content） ;column temperature：35 ℃. Results：The assay was liner over the range 2 -20 μg·mL^-1 （r =0.9999） with recoveries of 99. 8 %. The results are stable and reproducible. Conclusion：The method can be used for the qualitatively control of hydroxycamptothecin nano- emulsion injection.