高效液相色谱法测定羟尼酮及其胶囊的含量及有关物质

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(250 mm×4.6 mm,5 μm),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1 mL·min^-1;检测波长225 nm。 结果: 羟尼酮浓度在1~600 μg·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0.1 ng。 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 an HPLC-UV method for the determination of content and related substances of hydronidone and its capsules. Method: Waters Sunfire C₁₈ column(250 mm×4.6 mm,5 μm)was adopted.The mobile phase consisted of 0.05% triethylamine (adjust pH to 6.5 with glacial acetic acid)-methanol (50∶ 50) at the flow rate of 1 mL·min^-1with UV detection of 225 nm. Results: The linear range for the content of hydronidone was 1-600 μg·mL^-1(r=1.000,n=5).The average recoveries(n=3) were 100.6%,99.5% and 99.2%,respectively.The limit of detection was 0.1 ng. Conclusion: The method is specific,accurate and convenient to be used for the determination of content and related substances of hydronidone and its capsules.