The Blood Rotundine Determination And Its Bioequivalence Studies Of Orally-Disintegrating And Conventional Tablets In Chinese Healthy Volunteers

Objects: To establish an HPLC method for the determination of Rotundine in human plasma after oral administration of Rotundine disintegrating tablets and conventional tablets, to study its pharmacokinetics and to evaluate the bioequivalence of Rotundine disintegrating tablets and Rotundine conventional tablets.Method: Rotundine in human plasma was extracted and determined by HPLC method using Phenomenex luna C₁₈ (250mm×4.6mm,5μm) column and methanol-water (75:25, v/v) as mobile phase at ambient temperature, and the detection occurred at 281nm. Twenty healthy male volunteers were separated randomly into two groups according to body-weight and a single 60 mg of Rotundine disintegrating tablets, as test, or Rotundine conventional tablets, as reference, were orally given after 10 hours fasting overnight, respectively. Blood samples (4ml) were collected at scheduled time before and after administration. The plasma concnetrations of Rotundine were determined by established HPLC method after disposition and its pharmacokinetic parameters were calculated, and the bioequivalence of Rotundine test and reference was evaluated. The...