RP-HPLC Method for the Determination of Tenofovir in Pharmaceutical Formulations and Spiked Human Plasma

摘要

A simple reverse-phase high-performance liquid chromatographic method for the determination of tenofovir disoproxil fumarate (TDF) in pharmaceutical formulations and human plasma samples has been developed and validated. Piroxicam (PRX) was used as an internal standard. The assay of the drug was performed on a CLC C18 (5 m, 25 cm 4.6 mm i.d.) with UV detection at 259 nm. The mobile phase consisted of acetonitrile–water mixture in the ratio of 75:25, and a flow rate of 1 ml/min was maintained. The standard curve was linear over the range of 0.2–10 mg/ml (r2 0.9966). Analytic parameters have been evaluated. Within-day and betweenday precision as expressed by relative standard deviation was found to be less than 2%. The method has been applied successfully for the determination of TDF in spiked human plasma samples and pharmaceutical formulations.