Comparative Study on Three Quantitative Methods for Determination of Flavonoid Glycosides in Ginkgo biloba Oral Preparations
ZHONG Yuan-yuan1,2, WANG Jing-hui1*, CHEN Jing1, WANG Meng-meng1, GUO Hong-zhu1*, FU Xin-tong1, CHEN You-gen1
1. Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine, Beijing Institute for Drug Control, Beijing 102206, China;
2. Jinan Shanzhong Bencao Pharmaceutical Technology Co., Ltd., Ji′nan 250300, China
OBJECTIVE To establish a QAMS and a method for quantitative transfer of standardized control extracts to change the current status of controlling flavonoid glycosides in Ginkgo biloba preparations by means of indirect determination, thus making the control of flavonoid glycosides of Ginkgo biloba more accurate and reliable. METHODS The YMC-Pack ODS-AQ column (4.6 mm×250 mm, 5 μm) was adopted. The mobile phase consisted of acetonitrile-0.4% phosphoric acid and gradient elution was conducted at a flow rate of 1.0 mL·min-1. The detection wavelength was set at 360 nm. Five kinds of flavonoid glycosides in various oral preparations of Ginkgo biloba were determined by single marker(QAMS)method. Rutin was used as internal reference standard and the relative correction factors(RCFs)of KGR, IGR, KRG, QRcG and KRcG to rutin were calculated. The ginkgo flavonoid glycosides extract control was then prepared. Two batches of Ginkgo biloba extract control were demarcated,one was laboratory homemade, and the other was issued by the National Institutes for Food and Drug Control (NIFDC). RESULTS The RCFs determined by different instruments and columns at different concentrations and injection volumes had good reproducibility. The contents of flavonoid glycosides in the prepared ginkgo flavonoid glycosides extract control and Ginkgo biloba extract control were calibrated. No significant difference was found among the results of the above-mentioned three methods and the external standard method (P>0.05). CONCLUSION The four methods can all effectively and accurately determine the contents of flavonoid glycosides in various oral preparations of Ginkgo biloba. QAMS and standardized extract control method may achieve quantitative transfer. They can solve the problem of lack of reference substances and provide a feasible method for evaluating the quality of Ginkgo biloba oral preparations.
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ZHONG Yuan-yuan, WANG Jing-hui, CHEN Jing, WANG Meng-meng, GUO Hong-zhu, FU Xin-tong, CHEN You-gen. Comparative Study on Three Quantitative Methods for Determination of Flavonoid Glycosides in Ginkgo biloba Oral Preparations. Chinese Pharmaceutical Journal, 2019, 54(11): 916-921.
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