ArticleJournal of mass spectrometry : JMS2026
Analytical Method Development and Validation for Clofazimine in Human Plasma and Application of LC-MS/MS Based Methods for Clofazimine and Bedaquiline in Indian MDR-TB Patients Stratified by HIV Coinfection.
Article in Journal of mass spectrometry : JMS, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Determination of Hecogenin in Mouse Blood by UPLC-MS/MS and Applied to a Pharmacokinetic Study.Biomedical chromatography : BMC · 2026Article
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Authors and funding
17 authors.
Funding
Abstract
Multidrug-resistant tuberculosis (MDR-TB) remains a major cause of morbidity and mortality worldwide, with people living with HIV experiencing persistently poor treatment outcomes. Clofazimine and bedaquiline are cornerstone drugs in contemporary all-oral MDR-TB regimens, yet their complex pharmacokinetics and substantial interindividual variability complicate regimen optimisation, particularly in vulnerable populations. Robust plasma-based drug quantification is essential to characterise exposure-response relationships and inform individualised therapy. We developed and validated a rapid, sensitive and specific liquid chromatography-tandem mass spectrometry assay for quantifying these drugs in human plasma. The methods were successfully applied on plasma samples from study participants with MDR-TB with or without HIV coinfection who received clofazimine and bedaquiline as part of MDR-TB therapy assessing the Cmax, Tmax and AUC in both groups. The method addresses key analytical challenges posed by clofazimine's extreme lipophilicity and reliably quantifies concentrations across a broad, clinically relevant range, including potentially toxic exposures. Linearity was obtained between 0.0313 to 4.0 mg/L, and the method met bioanalytical method validation criteria along with interlab comparison with a reference laboratory, all within acceptable limits. We observed significantly lower Cmax concentrations of both drugs among HIV-infected participants compared to HIV-uninfected participants (p = 0.011 for clofazimine and p = 0.02 for bedaquiline), highlighting the need for therapeutic drug monitoring in this vulnerable group. This work provides a robust analytical foundation for pharmacokinetic, therapeutic drug monitoring and exposure-response studies of key MDR-TB drugs and supports efforts to optimise treatment outcomes, especially among people living with HIV.
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