A LC-MS method to quantify tenofovir urinary concentrations in treated patients

Area of Science:

• Pharmacology and Toxicology
• Analytical Chemistry
• Infectious Diseases

Background:

• Tenofovir disoproxil fumarate is a widely used antiretroviral for HIV and HBV.
• Renal and bone complications associated with tenofovir limit its clinical use.
• Urinary tenofovir concentration may predict tenofovir-related side effects, but no quantification method exists.

Purpose of the Study:

• To validate a novel liquid chromatography-mass spectrometry (LC-MS) method for quantifying tenofovir in human urine.
• To establish a reliable tool for monitoring tenofovir exposure and potential toxicity.

Main Methods:

• Development and validation of an LC-MS/MS method using reversed-phase chromatography.
• Analysis of urine samples from HIV-positive patients on tenofovir-based HAARTs.
• Determination of method performance characteristics including linearity, limit of quantification, and recovery.

Main Results:

• The validated LC-MS method demonstrated excellent linearity over a wide calibration range (391–100,000 ng/mL).
• The limit of quantification was 391 ng/mL, with low and stable matrix effects and consistent recovery.
• The method was successfully applied to urine samples from HIV patients, showing no significant interference from other drugs.

Conclusions:

• A robust and validated LC-MS method for urinary tenofovir quantification is now available.
• This method has the potential for clinical use in managing HIV patients treated with tenofovir.
• Monitoring urinary tenofovir may aid in predicting and mitigating renal and bone complications.