[Fingerprint research and multi-component quantitative analysis of Kumu injection by HPLC].
OBJECTIVE
To establish the HPLC chromatographic fingerprint of Kumu injection and to simultaneously determine the contents of three beta-carboline alkaloids, comprehensively evaluating the immanent quality of Kumu injection.


METHODS
The chromatographic analysis was performed on a Phenomenex Gemini C18 ( 4.6 mm x 250 mm, 5 microm) column with the gradient elution solvent system composed of methanol and 30 mmol x L(-1) aqueous ammonium acetate (adjusted with glacial acetic acid to pH 4.5). Similarity evaluation system for chromatographic fingerprint of traditional Chinese medicine (2004 A) was used in data analysis.


RESULTS
Sixteen co-possessing peaks were selected as the fingerprints of Kumu injection, and 7 peaks were identified by chemical reference substances. There were good similarities between the standard fingerprint chromatogram and each fingerprint chromatogram from the eleven samples for their similarity coefficients were not less than 0.9. Three kinds of beta-carboline alkaloids were separated well. The correlation coefficients were 0.999 9. The linear ranges of three components were 0.020 0-0.300 0, 0.102 0-1.530 0, 0.015 2-0. 228 0 microg, respectively, and the average recoveries ranged were from 99.5% to 102%.


CONCLUSIONS
The method of fingerprint combined with quantitative analysis is sensitive, selective, and provide scientific basis for quality control of Kumu Injection.
New Drug R&D Department, Guangzhou University of Chinese Medicine, Guangzhou 510006, China.
Zhengquan
Z
Lai
Yuyang
Y
Yi
Huijun
H
Liao
Jiyan
J
Su
Zhuyuan
Z
Liao
Ji
J
Lin
Ziren
Z
Su
D000470:Alkaloids / Q000032:analysis*; D002243:Carbolines / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004355:Drug Stability; D004365:Drugs, Chinese Herbal / Q000737:chemistry*; D007267:Injections; D019999:Pharmaceutical Solutions; D032270:Picrasma / Q000737:chemistry; D010946:Plants, Medicinal / Q000737:chemistry; D011786:Quality Control; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D000470:Alkaloids; D002243:Carbolines; D004365:Drugs, Chinese Herbal; D019999:Pharmaceutical Solutions