Abstract

COMPARISON OF BIOAVAILABILITY AND BIOEQUIVALENCE OF HERBAL ANXIOLYTIC DRUGS WITH MARKETED DRUG ALPRAZOLAM

Meera Sumanth*, Swathy Nedunuri

Abstract

If the herbal remedies have to prove as an alternate to the allopathic drug treatment, it is essential to understand it’s bioequivalence with allopathic drugs. In this study bioavailability and bioequivalence of Withania somnifera (Ashwagandha), Bacopa monnerie (Brahmi) is compared with Alprazolam. A single oral dose of 1mg/kg, 0.42gm/kg/day, 0.42 gm/kg/day of Alprazolam, Ashwagandha, Brahmi respectively, were administered to overnight fasted albino Rabbits (1.5-1.8 kg, either sex, n=6). Immediately after drug administration, 0.5 ml of blood was withdrawn at 0, 0.5, 1, 1.5, 2, 4, 6, 8, 12 and 24 hours from marginal ear vein, and plasma was extracted by liquidliquid extraction. About 20μl was injected into HPLC system. All the drugs were well absorbed with peak blood concentrations occurring at 1-2 hr. A significant decrease was found in Cmax and AUC of Withania somnifera and Bacopa monnerie. The relative bioavailability of Ashwagandha (60-70%) was found to be more significant than Brahmi when compared with Alprazolam. The bioequivalence of Ashwagandha with Brahmi and Alprazolam is Ashwagandha (14.25%) = Brahmi (18.42%) = Alprazolam (23.15%). Brahmi is more bioequivalent with Alprazolam as compared to Ashwagandha. The analysis using HPLC was found to be rapid, selective, accurate, precise, dependable and easy to perform.

Keywords: Bioavailability, Bioequivalence, HPLC, Withania somnifera, Bacopa monnerie, Alprazolam.