Stability investigations on Rumex crispus ethanolic extracts

One of the most important quality control criteria is the stability of the botanical drugs [1]. According to FDA, it is necessary to protect 95% of the composition to say that it maintains the stability of a product or drug [2]. In this study, the quality control of Rumex crispus (Polygonaceae) was carried out by stability tests and HPLC, which were accepted by the authorities.

Ethanolic extracts of roots, leaves and fruits are subjected to accelerated stability tests at conditions of 40 °C ± 2 °C, 75 ± 5% RH and 6,000 lux ± 10%. After 3 and 6 months the chemical profiles of the extracts were evaluated by HPLC. No microbiological contamination, weight loss and no change in physical properties were observed. All extracts protected physical stability and photostability. It has been found that all extracts maintain a chemical content of 95%.

The fact that the extracts are cap-free has not been found to be detrimental to stability, but the change in the amount of the substance is much less when they are closed. All of the stability tests and HPLC analyzes showed that Rumex crispus was stable for 6 months.

This study was supported by The Scientific and Technological Research Council of Turkey (TUBITAK) (Project No:SBAG-214S147.

[1] Connors KA, Amidon GL, Kennon L. Chemical stability of pharmaceuticals: a Handbook for Pharmacists: Wiley; 1979:367

[2] Fairweather WR, Lin TY, Kelly R. J Pharm Sci 1995; 84:1322 – 1326