Board A-09

Review and evaluation of methods for the analysis of commercial products containing Rauwolfia or Belladonna alkaloids

U.R.Cieri, FDA

Reserpine , rescinnamine and deserpidine, alkaloids obtained from the roots of Rauwolfia plants are used as hypotensive agents. Commercial products containing reserpine alone or in combination with a diuretic were very common thirty or forty years ago but their use has dropped dramatically in recent years because other more effective antihypertensive agents were developed and marketed. Today there are still a few products containing reserpine alone or in combination. Rescinnamine and deserpidine never enjoyed great popularity but occasionally a product containing one of these two alkaloids appears in the market. Atropine (d-l Hyoscyamine) sulfate and l-Hyoscyamine Sulfate, alkaloids obtained from Atropa belladonna or similar plants , have identical chemical structure but have different stereo configuration. Commercial products containing a belladonna alkaloid are used as anticholinergic, mydriatic or antidiarrheal agents. A review is presented of methods, both official and non official, for the analysis of commercial products containing a Rauwolfia or a Belladonna alkaloid. An evaluation is also made on the specificity and accuracy of each method; the issue of detecting impurities and degradants is also discussed briefly.


2003 FDA Science Forum | FDA Chapter, Sigma Xi | CFSAN | FDA
Last updated on 2003-MAR-20 by frf