HPLC-ELSD法测定抗肿瘤一类新药TRH-01及其胶囊的含量

Content determination of class Ⅰ new drug TRH-01 and its capsules by HPLC-ELSD

目的建立HPLC-ELSD法测定TRH-01及其胶囊的含量。方法采用Discovery C18（4.6 mm×250 mm,5μm）色谱柱,流动相为甲醇-水（55∶45）,流速1.0 mL.min-1,柱温35℃。结果TRH-01在10-1 000μg.mL-1线性关系良好（r=0.999 9）,最低检测限为0.4μg.mL-1,方法平均回收率99.6%,RSD=0.3%。结论该方法灵敏、准确、专属性好,可用于TRH-01及其胶囊的含量测定。

Objective To establish an HPLC-ELSD method for the content determination of TRH-01 and its capsules.Methods A C18 column（4.6 mm×250 mm,5 μm） was used with the mobile phase of methanol-water（55∶45）,the flow rate of 1.0 mL·min-1 and the column temperature of 35 ℃.Results The calibration curve of TRH-01 was linear at 101 000 μg·mL-1（r=0.999 9）.The detection limit was 0.4 μg·mL-1.The average recovery was 99.6% with RSD of 0.3%.Conclusion The method is sensitive,accurate and specific for the content determination of TRH-01 and its capsules.