Rapid and sensitive liquid chromatographic-tandem mass spectrometric methods for the quantitation of dolutegravir in human plasma and breast milk.

ABSTRACT:

Background

Dolutegravir (DTG) is part of a first-line antiretroviral therapy (ART) for HIV management in drug-naïve individuals and is recommended for the treatment of HIV during pregnancy. Robust analytical tools to quantify DTG are necessary to support clinical trials that characterize its multi-compartment drug distribution.

Methods

Potassium EDTA (K₂EDTA) plasma or whole breast milk was spiked with DTG and an isotopically labeled internal standard. Samples were prepared via protein precipitation prior to LC-MS/MS analysis. The assays were validated in accordance with regulatory recommendations.

Results

Analytical measuring ranges for DTG quantitation in plasma and breast milk were 100-10,000 ng/mL and 0.500 to 1000 ng/mL, respectively. Inter-assay preci

SUBMITTER: Rackow AR 

PROVIDER: S-EPMC11488435 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature