HPLC法测定曲匹布通片的含量及有关物质

HPLC determination of the content of trepibutone tablets and its related substances

目的:建立RP-HPLC法测定曲匹布通片的含量及有关物质。方法:采用Waters Symmetry^(?)C_(18)柱(4.6 mm×250 mm,5μm);流动相:甲醇-0.1 mol·L^(-1)醋酸(70:30);流速:1.0 mL·min^(-1);检测波长269 nm;柱温:30℃。结果:曲匹布通与杂质分离良好,在0.1023～0.9994 μg范围内呈较好的线性关系(r=1.000),检测限和定量限分别为1.509 μg,5.029 μg。结论:本法简便、准确,专属性好,灵敏度高。

Objective ： To establish an HPLC method for determination of compound trepibutone tablets and relative substances. Method ： Waters Symmetry C18 column （4.6 mm × 250 mm, 5 μm） was adopted with methanol - 0. 1 mol· L^-1 acetic acid （70： 30） as mobile phase at the flow rate of 1.0 mL · min^-1 ,detection was set at 269 nm, column temperature was 30℃. Results：Good separation of trepibutone and main related substance could be achieved. The standard curve was rectilinear in the range of 0. 1023 -0. 9994 μg（r = 1. 000）. The limit of detection and quantification was 1. 509 μg and 5. 029 μg respectively. Conclusion ： This method is simple, sensitive , selective and repetitive.