Development and validation of an UPLC-MS/MS bioanalytical method for simultaneous quantification of the antiretroviral drugs dolutegravir, elvitegravir, raltegravir, nevirapine and etravirine in human plasma.

07:00 EST 10th December 2018 | BioPortfolio

Summary of "Development and validation of an UPLC-MS/MS bioanalytical method for simultaneous quantification of the antiretroviral drugs dolutegravir, elvitegravir, raltegravir, nevirapine and etravirine in human plasma."

Dolutegravir, elvitegravir, raltegravir, nevirapine and etravirine are antiretroviral drugs used as part of combined antiretroviral treatment for HIV-infection. For quantification of these drugs in human KEDTA plasma samples an ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) bioanalytical method was developed and validated. Stable isotope labeled internal standards were used for each analyte. Simple protein precipitation with methanol was implemented to prepare plasma samples of at least 50 μL. The method was validated for dolutegravir, elvitegravir, raltegravir, nevirapine and etravirine over the ranges 9.7-9700, 52-10,470, 9.7-9730, 73-14,680 and 15-3010 ng/mL, respectively. Within-run and between-run accuracy and precision were within ±15% of the nominal concentration for quality controls at high, medium and low concentrations, and within ±20% at the lower limit of quantification for all analytes. Recovery was ≥76% and reproducible. Long-term stability of patient plasma samples was demonstrated for at least 12 months at -40 °C (4 months for etravirine). Currently, this robust method with a run time of 10 min is used in clinical research and for therapeutic drug monitoring of these frequently used antiretroviral drugs.


Journal Details

This article was published in the following journal.

Name: Journal of chromatography. B, Analytical technologies in the biomedical and life sciences
ISSN: 1873-376X
Pages: 76-84


DeepDyve research library

PubMed Articles [20718 Associated PubMed Articles listed on BioPortfolio]

Quantification of second generation direct-acting antivirals daclatasvir, elbasvir, grazoprevir, ledipasvir, simeprevir, sofosbuvir and velpatasvir in human plasma by UPLC-MS/MS.

Direct-acting antivirals (DAA) have markedly improved the treatment of hepatitis C, with a series of DAA combinations available for treatment. A sensitive method by ultra-high performance liquid chrom...

Simultaneous quantification of tegoprazan and its major metabolite M1 in dog plasma using liquid chromatography-tandem mass spectrometry.

Tegoprazan is a novel potassium-competitive acid blocker (P-CAB) recently approved in Korea as a next-generation therapeutics for gastric acid-related diseases. In the present study, we demonstrate a ...

Development and validation of a UPLC-MS/MS method for quantification of doxofylline and its metabolites in human plasma.

A sensitive and specific ultraperformance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and validated for simultaneous determination of doxofylline and its two metab...

Bioanalytical method validation: new FDA guidance vs. EMA guideline. Better or worse?

Bioanalysis concerns the identification and quantification of analytes in various biological matrices. Validation of any analytical method helps to achieve reliable results that are necessary for prop...

UPLC-MS/MS method for the simultaneous determination of imatinib, voriconazole and their metabolites concentrations in rat plasma.

In the present study, a simple ultra-performance liquid chromatography tandem mass spectrometry (UPLC-MS/MS) method used to measure the plasma concentrations of imatinib, voriconazole and their metabo...

Clinical Trials [6760 Associated Clinical Trials listed on BioPortfolio]

Dexamphetamine Sustained Release Pharmacokinetics and Clinical Validation of Dried Blood Spots

The pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. These individuals have received this medication before in a previous trial...

Validation of a Diagnostic Method for Quantification of Sleep Bruxism

This study aims to validate a new diagnostic method for quantification and monitoring of sleep bruxism.

Simultaneous Versus Sequential Antiretroviral Therapy (ARV) Therapy and Mycobacterium Tuberculosis (MTB) Treatment

The purpose of this study is to evaluate and compare the efficacy of immediate antiretroviral therapy versus 2 month deferred anti-Tb therapy upon the clinical course of tuberculosis and H...

Validation of Structured Light Plethysmography

Measurements of Structured Light Plethysmography (SLP) using a chest wall movement based method will be compared to those obtained by spirometry using a flow based pneumotachograph method....

Assessment of Flow With the New Four-dimensional Velocity-encoded Magnetic Resonance Imaging Technique

The purpose of our study is to validate the accuracy of 4D PC flow method in quantification of thoracic and upper abdominal blood flow volumes in children. In this validation study, 4D PC ...

Medical and Biotech [MESH] Definitions

The simultaneous, or near simultaneous, transference of heart and lungs from one human or animal to another.

A set of techniques used when variation in several variables has to be studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.

Simultaneous infection of a host organism by two or more pathogens. In virology, coinfection commonly refers to simultaneous infection of a single cell by two or more different viruses.

Validation of the SEX of an individual by inspection of the GONADS and/or by genetic tests.

Validation of the SEX of an individual by inspection of the GONADS and/or by genetic tests.

Quick Search


DeepDyve research library

Relevant Topics

AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...

Reverse Transcriptase
Reverse transcriptase (RT) is an enzyme used to generate complementary DNA (cDNA) from an RNA template, a process termed reverse transcription. It is mainly associated with retroviruses. RT inhibitors are widely used as antiretroviral drugs. RT activitie...

Searches Linking to this Article