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目的:建立高效液相色谱法测定甘露六烟酯的含量及其有关物质。方法:色谱柱为Agilent Extend-C18(250 mm×4.6 mm,5μm),以0.01 mol·L-1的醋酸铵水溶液-甲醇(40∶60)为流动相;检测波长为264 nm;柱温为30℃;流速为1.0 ml·min-1;进样量为10μl。结果:甘露六烟酯线性范围为53.6~1 072.8μg·ml-1(r=1.000 0),平均回收率为98.9%(RSD=0.4%,n=9)。样品中的杂质均能很好检出,各杂质与主峰之间的分离度良好,定量限为0.06μg·ml-1,检测限为0.02μg·ml-1。结论:本方法专属性强、准确、快速,适用于甘露六烟酯的质量控制。
Objective: To establish a HPLC method for the determination of hexa-nicotinate and its related substances. METHODS: The column was Agilent Extend-C18 (250 mm × 4.6 mm, 5 μm) with 0.01 mol·L-1 ammonium acetate in methanol (40:60) as the mobile phase. The detection wavelength was 264 nm. 30 ℃; flow rate of 1.0 ml · min-1; injection volume of 10μl. Results: The linear range of nerolidol was 53.6-1,072.8 μg · ml-1 (r = 1.000 0). The average recovery was 98.9% (RSD = 0.4%, n = 9). The impurities in the sample can be well detected, the separation between the impurities and the main peak is good, the limit of quantification is 0.06μg · ml-1, and the detection limit is 0.02μg · ml-1. Conclusion: The method is specific, accurate and rapid, and is suitable for the quality control of hexamyl niclosamide.