Studies on fingerprint of Shenkang injection

SUN Xiaomeng; BI Xueyan; QU Fanna; ZHANG Qingbo; YANG Huibing; ZHANG Xue; ZHOU Nan

doi:10.3969/j.issn.1006-0111.2019.06.014

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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.

Studies on fingerprint of Shenkang injection

1. Collage of Pharmacy, Heilongjiang University of Chinese Medicine, Haerbin 150040, China

2. Heilongjiang Institute for Food and Drug Control, Haerbin 150088, China

3. Heilongjiang Food and Drug Administration, Haerbin 150001, China

4. Xi'an Shi Ji Sheng Kang Pharmaceutical Industry Co., Ltd, Xi'an 710300, China

Received Date: 2018-11-14

Rev Recd Date: 2019-11-05

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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.

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Reference (8)

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Studies on fingerprint of Shenkang injection

doi: 10.3969/j.issn.1006-0111.2019.06.014

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