Development and validation of the methods for determination of tenophovir in the blood plasma of rabbits

• Published in: Sechenovskiĭ vestnik no. 3-4; pp. 24 - 30
• Main Authors: Yu. V. Medvedev, G. V. Ramenskaya, I. E. Shokhin, T. A. Yarushok, M. A. Sheveleva
• Format: Journal Article
• Language: Russian
• Published: Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University) 01.12.2022
• Subjects: derivatization; hplc; plasma; rabbits; tenofovir
• ISSN: 2218-7332; 2658-3348

Scribes development and validation of HPLC method with UV detection at 260 nm for determination of tenofovir in rabbit plasma. Plasma samples were treated by protein precipitation using methanol. HPLC analysis was performed on Waters Atlantis T3 column (5 μm, 4,6 x 150 mm), with precolumn Waters Atlantis T3 (5 μm, 4,6 x 20 mm). Acetonitrile –phosphate buffer pH 5.70 (16:84) at 1.0 mL/min was used as mobile phase. The standard curve was linear over the range 0.23 μg/ml to 112,98 μg/ml of tenofovir in plasma. Method precision (RSD, %) was 6.08 % to 12.36 % determined on spiked samples. The accuracy of the method (ε, %) was – 2.96 % to 14.55 %. The lower limit of quantification was 0.23 μg/ml. The method was applied to preclinical pharmacokinetics study of tenofovir drug products in rabbits.