鸦胆子油乳注射剂HPLC-ELSD指纹图谱分析

HPLC-ELSD Fingerprint of Bruceae Fructus Oil Latex Injection

摘要:

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,5 μm),流动相乙腈-二氯甲烷(65:35),流速1.0 mL ·min^-1,检测温度70 ℃,柱温30 ℃,进样量10 μL.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.

Abstract:

Objective: To establish a method of fingerprint analysis on Brucea Javanica oil latex Injection by HPLC-ELSD and provide a reference for the quality evalation of Brucea Javanica oil latex Injection. Method: The sample were determined by shimadzu 2010C HPLC and Alltech 2000 ESLD with Waters C₁₈ analytical column (4.6 mm×250 mm, 5μm) , by using acetonitrile-dichloromethane(65: 35) as the mobile phase at the flow rate of 1.0 mL · min^-1 and the detection temperature of 70 ℃, column temperature 30 ℃, inject volume 10 μL. Result: Its fingerprint exhibited better separation for each peak, revealing amount of finger information, based on the ten batches of Brucea Javanica oil latex Injection, eight common peaks were selected in chromatograms. The precision reproducibility and stability of the method is good, and RSD of the relative retention time and relative peak area were less than 3.0%, the similarity is greater than 0.99, according to the technical requirements of fingerprint on Chinese tradirional medicine . Conclusion: Proposed HPLC fingerprint is convenient, reliable and can be used as the important evidences for the quality control of Brucea Javanica oil latex Injection.