Liquid chromatography metabolite profiling of tenofovir disoproxil fumarate

Abstract

Reverse transcriptase inhibitors are the most frequently prescribed agents for HIV infections. This publication presents a validated, highly sensitive and selective isocratic HPLC method for the quantitative determination of tenofovir disoproxil fumarate and its metabolite tenofovir. Detection was performed on a UV detector. The linearity for the calibration curve in the concentration range of 80-20400 ng/mL for tenofovir disoproxil fumarate (TENDF) and 10-2560 ng/mL for tenofovir (TEN) is presented. Inter- and intra-day precision and accuracy of the proposed method were characterised by relative standard deviation (R.S.D.) and percentage deviation, respectively: with both lower than 4% for all analytes. The limit of detection was 33.46 ng/mL for TENDF and 2.10 ng/mL for TEN.

Keywords

• hplc
• metabolite
• metabolite profiling
• prodrug
• tenofovir