HPLC法测定阿魏酸哌嗪的有关物质

Determination of Related Substances in Piperazine Ferulate by HPLC

目的:建立阿魏酸哌嗪有关物质的测定方法。方法:采用HPLC法,色谱柱:Xtimate C_(18)柱(250 mm×4.6 mm,5μm);流动相:0.5%冰乙酸溶液-甲醇-乙腈,采用梯度洗脱;流速:1.0 ml·min^(-1);柱温:30℃;检测波长:286 nm;进样量:20μl。结果:阿魏酸在5~30μg·ml^(-1)(r=1.000 0)浓度范围内线性关系良好,检测限为0.02 ng。结论:本测定方法可靠、简便、结果准确,稳定性和耐用性良好,适用于阿魏酸哌嗪有关物质的测定。

Objective ： To establish an HPLC method for the determination of related substances in piperazine ferulate. Methods： An HPLC method was used to determine the related substances in piperazine ferulate. The separation was performed on an Xtimate C18 column （250 mm ×4.6 ram, 5 μm）. The mobile phase was 0.5% acetic acid-methanol-acetonitrile with gradient elution. The flow rate was 1.0 ml min-1 and the column temperature was 30℃. The detection wavelength was 286 om and the injection volume was 20 μl. Results： Ferulic acid had a good linear relationship within the range of 5-30 μg ml-1（r = 1. 000 0）. The detection limit was 0.02 ng. Conclusion： The method is reliable, simple, accurate, stable and durable, and suitable for the determination of related sub- stances in piperazine ferulate.