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目的:建立鸦胆子油乳注射剂的HPLC-ELSD指纹图谱,为科学评价其质量提供依据。方法:运用岛津2010C高效液相色谱仪和奥泰2000蒸发光检测器,采用Waters C18色谱柱(4.6 mm×250 mm,5μm),流动相乙腈-二氯甲烷(65∶35),流速1.0 m L·min-1,检测温度70℃,柱温30℃,进样量10μL。结果:在10批鸦胆子油乳注射剂基础上,建立了有8个共有峰的鸦胆子油乳注射剂的HPLC-ELSD色谱图,方法的精密度、重复性与稳定性良好,相对保留时间和相对峰面积的RSD均<3.0%,相似度均>0.99,各峰分离度良好,指纹信息完整,符合指纹图谱技术规范。结论:所建方法简单、可靠,可作为鸦胆子油乳注射剂质量控制的重要依据之一。
OBJECTIVE: To establish HPLC-ELSD fingerprint of Brucea javanica oil emulsion injection and provide scientific basis for evaluating its quality. Methods: Waters C18 column (4.6 mm × 250 mm, 5 μm) was used with Shimadzu 2010C high performance liquid chromatography and Altai 2000 evaporating detector. The mobile phase was acetonitrile-dichloromethane (65:35), the flow rate was 1.0 m L · min-1, detection temperature 70 ℃, column temperature 30 ℃, injection volume 10μL. Results: The HPLC-ELSD chromatogram of Brucea javanica oil emulsion injection with eight common peaks was established on the basis of 10 batches of Brucea javanica oil emulsion injection. The method has good precision, repeatability and stability, relative retention time and relative The RSDs of peak area were all less than 3.0%, and the similarities were all> 0.99. The peak separation was good and the fingerprint information was complete, which accorded with the fingerprinting specification. Conclusion: The method is simple and reliable, which can be used as an important basis for the quality control of Brucea javanica oil emulsion injection.