中国药物警戒 ›› 2015, Vol. 12 ›› Issue (11): 652-655.

• 质量与工艺研究 • 上一篇    下一篇

超高效液相色谱法同时测定复方紫灵胶囊中的补骨脂素与异补骨脂素的含量

江丽, 龚春燕*   

  1. 中国医学科学院皮肤病医院药剂科,江苏 南京 210042
  • 收稿日期:2016-02-02 修回日期:2016-02-02 出版日期:2015-11-08 发布日期:2016-02-02
  • 通讯作者: 龚春燕,女,副主任药师,主任,医院药学。E-mail:13057687408@163.com
  • 作者简介:江丽,女,硕士,主管药师,药品体内外质量标准。
  • 基金资助:
    2010年江苏省药学会奥赛康临床药学科研基金（201014）

Determination of Psoralen and Isopsoralen in Compound Ziling Capsules by UPLC

JIANG Li , GONG Chun-yan*   

  1. Dermatological Hospital, Chinese Academy of Medical Sciences Jiangsu Najing 210042, China
  • Received:2016-02-02 Revised:2016-02-02 Online:2015-11-08 Published:2016-02-02

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摘要： 目的建立超高效液相色谱法（UPLC）同时测定复方紫灵胶囊中补骨脂素和异补骨脂素的含量。方法采用ACQUITY UPLC BEH C18 色谱柱（2.1 mm×100 mm,1.7 m）,流动相为0.05%甲酸-甲醇（50∶50）,流速：0.2 mL·min-1,检测波长246 nm,柱温为35℃。结果补骨脂素在10~200 mg·L-1范围内有良好线性关系（r=0.9996）,平均加样回收率为 100.69%,精密度良好（RSD=1.38%）。异补骨脂素在10~200 mg·L-1范围内有良好线性关系（r=1.000 0）,平均加样回收率为 100.67%,精密度良好（RSD=1.29%）。结论本方法测定复方紫灵胶囊中补骨脂素和异补骨脂素的含量,方法简便、准确,结果稳定,可为复方紫灵胶囊的质量评价提供科学依据。

关键词: 复方紫灵胶囊, 补骨脂素, 异补骨脂素, 超高效液相色谱法

Abstract: Objective To establish an ultra performance liquid chromatography (UPLC) method for the determination of psoralen and isopsoralen in compound Ziling capsules. Methods The separation was performed on ACQUITY UPLC BEH C18(2.1 mm× 100 mm, 1.7 m) with 0.05% formic acid：methamol (50∶ 50) mixture as mobile phase at a flow rate of 0.2 mL·min-1, and UV detection at 246 nm. Results The calibration curves for psoralen and isopsoralen were linear in the range of 10~200 mg·L-1 (rPsoralen=0.999 6, rIsopsoralen=1.000 0). The average recoveries of psoralen and isopsoralen were (100.69± 1.38)% and (100.67± 1.29)%, respectively. Conclusion The method was simple, accurate and reliable for the quality control of compound Ziling capsules.

Key words: compound Ziling capsules, psoralen, isopsoralen, UPLC

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