米拉贝隆中3种降解杂质的UPLC测定

发布时间：2018-05-26 17:41

  本文选题：米拉贝隆 + 降解杂质　； 参考：《中国医药工业杂志》2017年10期

【摘要】：建立了超高效液相色谱(UPLC)法测定米拉贝隆原料药中的3种降解杂质。采用Acquity UPLC BEH C_(18)色谱柱,以5 mmol/L庚烷磺酸钠溶液∶20 mmol/L磷酸二氢钾溶液(用磷酸调至pH 3.0)为流动相A,以乙腈为流动相B,线性梯度洗脱,检测波长220 nm。采用加校正因子的主成分自身对照法,以米拉贝隆为参照物,分别测定其与降解杂质之间的相对保留时间(RRT)及相对校正因子(RCF),以RCF对米拉贝隆中的3种降解杂质进行定量分析,并与标准曲线法测定结果比较,以验证方法的准确性。3种降解杂质的RRT分别为0.53、0.78和1.22;RCF分别为1.38、1.63和1.25;RCF法与标准曲线法测定结果无显著性差异。本方法能够准确测定米拉贝隆原料药中的3种降解杂质。
[Abstract]:A high performance liquid chromatography (UPLC) method was developed for the determination of three degradable impurities in Milabelon. The mobile phase A was 5 mmol/L sodium heptane sulfonate solution: 20 mmol/L potassium dihydrogen phosphate (adjusted to pH 3.0 with phosphoric acid) and the mobile phase B was acetonitrile. The detection wavelength was 220nm. The relative retention time (RRT) and the relative correction factor (RCF) between Mira Belon and the degradation impurities were determined by using the principal component self-control method with correction factor. The three kinds of degradation impurities in Mirabelon were quantitatively analyzed by RCF. Compared with the standard curve method, the accuracy of the method was not significantly different from that of the standard curve method. The RRT of the three kinds of impurities were 0.53 ~ 0.78 and 1.22 ~ 0.78, 1.38 ~ (1.63) and 1.25 ~ (%), respectively. This method can accurately determine three kinds of degradation impurities in Milabelon.
【作者单位】： 莒县人民医院;临沂莱博医药技术有限公司;
【分类号】：O657.72;TQ460.72
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本文编号：1938239