ABSTRACT
Objective: To develop a method of quantitative analysis of multi-components by single marker (QAMS) for six active ingredients in Gualoupi injection. Methods: An HPLC method was used with a Waters Sunfire ODS C18column (250 mm×4. 6mm, 2. 5 μm), the mobile phase was methanol(A)-0. 2% glacial acetic acid solution(B) with gradient elution, the flow rate was 1. 0 ml· min-1,the detection wavelength was 254 nm,the column temperature was 30℃ and the injection volume was 20 μl. Using 3, 29-dibenzoyl rarounitriol as a reference, the relative correction factors among karounidiol, vanillic acid, adenosine, quercitrin and cynaro-side were detected by QAMS and their contents were calculated, and the results were compared with those of the external standard method. Results: The differences were not statistically significant between the calculated values of karounidiol, vanillic acid, adeno-sine, quercitrin and cynaroside and those measured by the external standard method (P>0. 05). Conclusion: QAMS can be used for the determination of 6 effective components in Gualoupi injection, and the result is accurate, simple and effective.
ABSTRACT
Objective To establish the HPLC multi-index quantitative fingerprints of Xiao’er Xiaoji Zhike Oral Liquid (XXZOL), and to provide methods and technical support for improving its quality standard. Methods Using an Agilent Zorbax SB-C18 (250 mm × 4.6 mm, 5.0 μm) column, acetonitrile-0.4% glacial acetic acid mobile phase system, gradient elution, flow rate of 0.6 mL/min, column temperature 25 ℃, detection wavelength 254 nm; The HPLC-ESI-Q-TOF/MS technique was used to identify the chemical constituents (peak 1-synephrine, peak 13-chlorogenic acid, peak 16-quercetin-3-O-β-D-glucose-7-O-β-D-gentiobioside, peak 22-hyperoside, peak 24-forsythoside A, peak 26-naringin, peak 27-hesperidin, peak 29-neohesperidin, peak 33-phillyrin, peak 37-3,29-dibenzoyl rarounitriol) in the XXZOL, and the content of the main components was determined by HPLC-DAD. The HPLC fingerprint was established on the basis of multi-batch analysis. Results The fingerprints of the 10 batches of samples were established, and the similarities of them were above 0.9, which were 0.999 3, 0.999 6, 0.999 2, 0.999 2, 0.999 4, 0.999 3, 0.999 4, 0.999 5, 0.999 1, and 0.999 7, respectively. XXZOL has 38 common peaks, 32 of them was identified, six of them was unknown; the contents of the 10 chemical constituents were 2 542.42, 158.61, 147.02, 34.35, 432.42, 1 813.01, 1 339.70, 2 580.71, 175.32, and 1 615.17 μg/mL. Conclusion The establishment of multi-index analysis by HPLC and fingerprints of XXZOL provides a scientific basis for improving its quality standards.