Исследование биоэквивалентности препаратов ондансетрона с использованием метода ВЭЖХ-МС

Within the cross, a single, open, randomized study with a week washout period, the two sequences has been studied bioequivalence of tablet forms two ondansetron 18 volunteers (8 mg dosage). Plasma samples were analyzed by a validated HPLC-MS, tropisetron was used as the internal standard. Limit of quantification was 1 ng/ml. Analyzed for drugs following pharmacokinetic parameters were calculated: AUC 0-t, C max, T max, MRT, C max/AUC '' 90% confidence interval for log-transformed values of AUC 0-t was 0,9507 1,0037, of AUC (0-∞ ). was 0,9402-0,9974, of C was 0,9255 1,0095. The study concluded that bioequivalence compared ondansetron drugs.