FWD 2 Botanical Adulterants Monitor


Alleged Passionflower Adulteration

The Botanical Adulterants Program (BAP) was notified by Laboratoires Arkopharma, SA (Carros, France) about the appearance of several batches of adulterated passionflower (Passiflora incarnata, Passifloraceae) herb extracts. The adulteration was detected using a high-performance thin-layer chromatography (HPTLC) method by the in-house analytical development unit. A comparison with authentic standards showed that the chemical fingerprint of the adulterant (Figure 1), which contains large amounts of rutin, is very different from authentic passionflower herb extracts. Apparently, the fingerprint of the adulterant is very similar to extracts of Japanese sophora (Styphnolobium japonicum, syn. Sophora japonica, Fabaceae) (Fanny Perraudin, research scientist at Arkopharma, oral communication, June 8, 2015).




Figure 1: HPTLC assay to detect adulteration of passionflower extracts. Lanes 1 and 10 (last): standard compounds (rutin, hyperoside, vitexin, from bottom to top); lane 2: extract made from botanically authenticated passionflower herb; lanes 3-9: various hydroethanolic passionflower herb extracts, with EC007861 (Lane 4), EC007867 (Lane 6), and EC008212 (Lane 7) showing a non-conforming fingerprint and the presence of an adulterant.
Image courtesy of Laboratoires Arkopharma, SA.

Another case of passionflower extract adulteration was documented by PhytoLab GmbH & Co. KG (Vestenbergsgreuth, Germany). According to their test results, the extract was spiked with rutin. The company is currently gathering samples from the US and German markets and will perform a more thorough investigation of the issue.

Comment: The occurrence of passionflower herb adulteration is rare to our knowledge. The current problem may be due to a supply shortage (Fanny Perraudin e-mail communication, July 17, 2015) that is exploited by unscrupulous manufacturers who resort to spiking with pure flavonoids or flavonoid-rich extracts. Adulteration with rutin, or extracts of Japanese sophora, is readily detected by chromatographic means but may go unnoticed when relying only on the total flavonoid content assay using UV/Vis spectrophotometry, e.g., the method detailed in the Passiflorae herba or Passiflorae herbae extractum siccum monographs of the current European Pharmacopoeia.1,2 According to Fanny Perraudin, a revision of the European Pharmacopoeia monograph is under way. The new monograph3 aims to replace the spectrometric UV/Vis assay for total flavonoids by an HPLC method measuring isovitexin (e-mail communication, August 18, 2015).

References

1.     The European Directorate for the Quality of Medicines & HealthCare. European Pharmacopoeia (EP 8.4). Passiflorae herbae extractum siccum. Strasbourg, France: Council of Europe; 2014.
2.     The European Directorate for the Quality of Medicines & HealthCare. European Pharmacopoeia (EP 8.4). Passiflorae herba. Strasbourg, France: Council of Europe; 2014.
3.     The European Directorate for the Quality of Medicines & HealthCare. Pharmeuropa 27.01. Passiflorae herbae extractum siccum. Strasbourg, France: Council of Europe; 2015.
Note: The evidence for the above-reported case of adulteration is based on unpublished internal data gathered by the respective companies but has not been independently verified by a third-party analytical laboratory.