论文部分内容阅读
目的建立HPLC-ELSD测定美他多辛注射液有关物质的方法。方法色谱柱为Agilent Zorbax SB-C18柱(250 mm×4.6 mm,5μm),流动相为0.2 mol.L 1三氟乙酸溶液-甲醇(92∶8),流速为1.0 mL.min 1,检测器漂移管温度为55℃(低温型),载气压力为420 Pa。结果主要杂质与美他多辛有较好的分离度,所建立的方法可有效检测无紫外吸收的杂质。结论方法简单、可靠,适用于美他多辛的质量控制。
OBJECTIVE To establish a HPLC-ELSD method for the determination of related substances in metradoxine injection. Methods The column was Agilent Zorbax SB-C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of 0.2 mol·L -1 trifluoroacetic acid-methanol (92: 8) at a flow rate of 1.0 mL · min -1. The detector Drift tube temperature 55 ℃ (low temperature type), carrier gas pressure 420 Pa. Results The main impurities with meadowsutin have better resolution, the established method can effectively detect non-UV absorption of impurities. Conclusion The method is simple and reliable and is suitable for the quality control of metyldoxine.