Studies on fingerprint of Shenkang injection
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摘要: 目的 建立肾康注射液的超高效液相色谱(UPLC)指纹图谱,并对肾康注射液指纹图谱共有峰进行鉴定。 方法 采用超高效液相色谱条件法,色谱柱ACQUITY UPLC® CSH-C18(2.1mm×100mm,1.7μm),甲醇(A)-0.1%甲酸溶液(B)二元梯度洗脱,流速0.4 ml/min,检测波长280 nm,进样量2 μl,柱温30℃,使用飞行时间质谱仪,负离子模式扫描。 结果 建立了肾康注射液UPLC指纹图谱,采用UPLC/ESI-Q-TOF MS技术共鉴定了26个共有峰。采用《中药指纹图谱相似度评价系统(2012.130723版)》评价了20批肾康注射液,指纹图谱相似度均大于0.90。 结论 本方法所建立的肾康注射液指纹图谱灵敏度高,稳定可靠,为肾康注射液的质量控制提供了科学依据。
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关键词:
- 肾康注射液 /
- 指纹图谱 /
- 液相色谱-质谱联用技术
Abstract: Objective To establish an ultra-high performance liquid chromatography (UPLC) fingerprint of Shenkang injection and identify the common peaks of Shenkang injection fingerprint. Methods The UPLC method was established by employing ACQUITY UPLC® CSH-C18 column(2.1 mm×100 mm,1.7 μm) with methanol(A) -0.1% formic acid(B) aqueous solution as mobile phase in gradient elution.The detection wavelength was 280 nm.The flow rate was 0.4ml/min.The injection volume was 2 μl and the column temperature was 30℃.Time of flight mass spectrometer was used with negative ion mode scanning. Results The UPLC chromatographic fingerprint of Shenkang injection was established.26 common peaks of shenkang injection were identified by UPLC/ESI-Q-TOF MS.The similarity of 20 batches of shenkang injection was over 0.90,which was evaluated by similarity evaluation system for chromatographic fingerprint of TCM(Version 2012.130723). Conclusion This method is highly sensitive,stable and reliable,and can be used for the quality control of shenkang injection.-
Key words:
- Shenkang injection /
- fingerprint /
- UPLC/ESI-Q-TOF MS
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