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目的:建立高效液相色谱法检测羟尼酮原料及其胶囊的含量和有关物质。方法:Waters Sunfire C18柱(250mm×4.6mm,5μm),以甲醇-0.05%三乙胺缓冲溶液(冰醋酸调pH为6.5)(50∶50)为流动相,流速1mL·min-1;检测波长225nm。结果:羟尼酮浓度在1~600μg.mL-1范围内,与峰面积呈良好的线性关系(r=1.000,n=5);平均回收率(n=3)分别为100.6%,99.5%,99.2%;最低检测限为0.1ng。结论:本法简单、快速,专属性强,适用于测定羟尼酮及其胶囊的含量和有关物质。
Objective: To establish a high performance liquid chromatography for the determination of hydroxynine and its capsule content and related substances. METHODS: Waters Sunfire C18 column (250 mm × 4.6 mm, 5 μm) was used with a mobile phase of methanol-0.05% triethylamine buffer (adjusted to pH 6.5 with glacial acetic acid) (50:50) at a flow rate of 1 mL · min -1. Wavelength 225nm. Results: The concentration of hydroxycycline in the range of 1 ~ 600μg.mL-1 showed a good linear relationship with the peak area (r = 1.000, n = 5). The average recoveries were 100.6%, 99.5% , 99.2%; the lowest detection limit was 0.1ng. Conclusion: This method is simple, rapid and specific, suitable for the determination of content and related substances of hydroxyketone and its capsule.