Bioequivalence study of ondansetron tablets by HPLC-MS
Abstract
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: AUC0-t, Cmax, Tmax, MRT, Cmax/AUC ' 90% confidence interval for log-transformed values of AUC0-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.
About the Authors
E. S. Stepanova
Peoples' Friendship university of Russia
Russian Federation
Russian Federation
M. V. Ovcharov
Peoples' Friendship university of Russia
Russian Federation
Russian Federation
S. S. Barsegyan
Peoples' Friendship university of Russia
Russian Federation
Russian Federation
S. M. Nikonova
Peoples' Friendship university of Russia
Russian Federation
Russian Federation
V. V. Shilov
Science Center «Hygiene and Public Health»
Russian Federation
Russian Federation
V. V. Chistyakov
Science Center «Hygiene and Public Health»
Russian Federation
Russian Federation
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Review
For citations:
Stepanova E.S., Ovcharov M.V., Barsegyan S.S., Nikonova S.M., Shilov V.V., Chistyakov V.V. Bioequivalence study of ondansetron tablets by HPLC-MS. Pharmacokinetics and Pharmacodynamics. 2015;(1):21-26. (In Russ.)
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