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Abstract Dietary supplements containing Ginkgo biloba L. are of the top best-selling botanicals in the world. They are used in the treatment of Alzheimer‘s disease, neurodegenerative disease, cerebral insufficiency, and eye ailments. The major contributors to the positive biological effects attributed to Ginkgo are flavonol glycosides and terpene trilactones. The flavonol glycosides are mainly derivatives of quercetin, kaempferol, and isorhamnetin aglycones. The aglycones themselves occur only in relatively low concentration in extracts. Approximately 35 flavonoids have been isolated from Ginkgo biloba L.. Five coumaroyl esters of Ginkgo flavonoids have been isolated and identified. Coumaroyl esters of Ginkgo flavonol glycosides are unstable because of the presence of two centres of instability. Accordingly, stability indicating method of assay for flavonol glycosides is essential. Ginkgolic acids are negative markers found in Ginkgo biloba L. leaves and extracts. Monographs for Ginkgo extract can be found in various pharmacopoeias, including the USP, Ph. Eur., and the BP. The USP monograph for Ginkgo extract specifies a flavonoid content of 22-27%, calculated as flavonol glycosides, terpene trilactones content of 5.4-12% consisting of bilobalide ,ginkgolide A, ginkgolide B, and ginkgolide C, and a maximum content of 5 ppm for ginkgolic acids. As a parameter for quality/authenticity the USP method also mandates to monitor a quercetin/kaemferol/isorhamnetin ratio of the hydrolysed extract based on their respective peak areas. The kaempferol peak must be 0.8- 1.2 times the size of the quercetin peak, and the peak for isorhamnetin must be not less than 0.1 times the size of quercetin peak. The current USP method for the assay of flavonol glycosides content, in Ginkgo biloba L. extract, is non-stability indicating. It involves acid hydrolysis of flavonol glycosides to aglycones and back calculates the total flavonol glycoside content from the aglycone concentration in extracts. This means that the prescribed assays quantify flavonol aglycones and not the flavonol glycosides. The latter are responsible for the claimed activity. Accordingly the pharmacopoeial methods are not capable of detecting adulteration of Ginkgo extract with free flavonol aglycones. Although the quercetin/kaemferol/isorhamnetin ratio can detect inferior quality products containing Ginkgo biloba L. extracts; however it might fail to detect counterfeiting with aglycones. Terpene trilactones are unique components of Ginkgo biloba L. and they are expensive to purchase. Accordingly, literature survey does not document counterfeiting with these compounds. However, the defect in the USP method for the assay of terpene lactones is the use of refractive index detector with questionable sensitivity. |