Validation and application of a quantitative LC-MS/MS assay for the analysis of first-line anti-tuberculosis drugs, rifabutin and their metabolites in human breast milk

Zuma, Phiwe; Joubert, Anton; Merwe, Marthinus van der; Norman, Jennifer; Waitt, Catriona; Court, Richard; Loveday, Marian; Castel, Sandra; Wiesner, Lubbe

doi:10.1016/j.jchromb.2022.123489

Cited by 7 publications

(11 citation statements)

References 24 publications

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“…The present auto-μ-SPE method coupled with LC-MS/MS was optimized for the analysis of 16 anti-TB drugs in a single method with advantages with respect to percent recoveries, repeatability, and sensitivity in comparison to earlier reported methods [31][32][33][34][35][36]. The auto-μ-SPE method has good extraction efficiency, with less time, less solvent consumption, accuracy, and precision for all 16 anti-TB drugs.…”

Section: Comparison Of the Present Methods With Earlier Reported Methodsmentioning

confidence: 99%

Development, validation, and measurement uncertainty estimation of automated micro‐solid‐phase extraction coupled with liquid chromatography‐triple quadrupole mass spectrometry for the quantitative determination of anti‐tuberculosis drugs in milk samples

Thati

Subrahanyam

Shaik

et al. 2023

Separation Science Plus

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Milk is one of the most widely consumed animal‐derived food due to its nutritional properties. It is mainly derived from animals, which are being treated with anti‐tuberculosis (anti‐TB) drugs for disease treatment and prevention, hence, these may excrete from animals through milk, thus, pose a threat to consumers. An analytical method based on automated micro‐solid phase extraction coupled to liquid chromatography‐triple quadrupole mass spectrometry was developed for the analysis of anti‐TB drugs in milk samples. The developed method was validated and estimated measurement uncertainty for its applicability to routine analysis. The method linearity was in the range of 25–1000 ng/ml with a coefficient of determination between 0.994 and 0.999. The limit of detection and limit of quantification were in the range of 1.342–9.606 and 4.469–31.98 ng/ml, respectively for anti‐TB drugs. The percent recovery was found to be in the range of 82.29%–111.84%, and the expanded uncertainty of the proposed and validated method was observed to be in the range of 2.94%–28.1%. The present method has been able to analyze 16 anti‐TB drugs in different milk samples and was found to be quick, rapid, high‐throughput, cost‐effective, precise and accurate, and useful for routine testing of anti‐tuberculosis drugs in milk samples.

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Section: Comparison Of the Present Methods With Earlier Reported Methodsmentioning

confidence: 99%

Development, validation, and measurement uncertainty estimation of automated micro‐solid‐phase extraction coupled with liquid chromatography‐triple quadrupole mass spectrometry for the quantitative determination of anti‐tuberculosis drugs in milk samples

Thati

Subrahanyam

Shaik

et al. 2023

Separation Science Plus

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show abstract

“…Therefore, methods for TDM characterizing the PK and interaction of these drugs simultaneously (combined with other agents, such as β-lactams) have been developed. These approaches are summarized in Table 3 [ 9 , 18 , [20] , [21] , [22] , 64 , [76] , [77] , [78] , [79] , [80] , [81] , [82] , [83] , [84] , [85] , [86] ]. We omitted some drugs not typically used in TB, such as ceftazidime, teicoplanin, and tigecycline [ 77 , 78 ].…”

Section: Tdm Of Anti-tb Drugs Based On Lc-ms/msmentioning

confidence: 99%

“…Another study was conducted on breast milk matrix using six different sources, and the influence of matrix effects was found insignificant. The method was successfully applied to breast milk samples taken from breastfeeding women treated with H, E, and Z, as well as provided an opportunity to quantify R, Rfb, and their metabolites facilitating clinical practice [ 86 ].…”

Section: Tdm Of Anti-tb Drugs Based On Lc-ms/msmentioning

confidence: 99%

Push forward LC-MS-based therapeutic drug monitoring and pharmacometabolomics for anti-tuberculosis precision dosing and comprehensive clinical management

Thu,

Tien,

Yen

et al. 2024

Journal of Pharmaceutical Analysis

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“…The maximum concentration in the milk was 1.5 µg/mL at 3 h whereas the peak plasma concentration of 42.0 µg/mL was observed at 2 h. No information was given concerning the concentration-time course in the plasma nor in the milk. Using a specifically developed method for measurements in milk, three milk concentrations were determined 2, 4 and 6 h after an oral dose of 1750 mg (somewhat more than the standard dose of 1500 mg) was given to two nursing women [77]. The quality of this study was rated poor (7/19 points) because of a lack of information on the two participants, the clinical setting and the study design.…”

Section: Kineticsmentioning

confidence: 99%

Infant Exposure to Antituberculosis Drugs via Breast Milk and Assessment of Potential Adverse Effects in Breastfed Infants: Critical Review of Data

2023

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Infants of mothers treated for tuberculosis might be exposed to drugs via breast milk. The existing information on the exposure of breastfed infants lacks a critical review of the published data. We aimed to evaluate the quality of the existing data on antituberculosis (anti-TB) drug concentrations in the plasma and milk as a methodologically sound basis for the potential risk of breastfeeding under therapy. We performed a systematic search in PubMed for bedaquiline, clofazimine, cycloserine/terizidone, levofloxacin, linezolid, pretomanid/pa824, pyrazinamide, streptomycin, ethambutol, rifampicin and isoniazid, supplemented with update references found in LactMed®. We calculated the external infant exposure (EID) for each drug and compared it with the recommended WHO dose for infants (relative external infant dose) and assessed their potential to elicit adverse effects in the breastfed infant. Breast milk concentration data were mainly not satisfactory to properly estimate the EID. Most of the studies suffer from limitations in the sample collection, quantity, timing and study design. Infant plasma concentrations are extremely scarce and very little data exist documenting the clinical outcome in exposed infants. Concerns for potential adverse effects in breastfed infants could be ruled out for bedaquiline, cycloserine/terizidone, linezolid and pyrazinamide. Adequate studies should be performed covering the scenario in treated mothers, breast milk and infants.

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Validation and application of a quantitative LC-MS/MS assay for the analysis of first-line anti-tuberculosis drugs, rifabutin and their metabolites in human breast milk

Cited by 7 publications

References 24 publications

Development, validation, and measurement uncertainty estimation of automated micro‐solid‐phase extraction coupled with liquid chromatography‐triple quadrupole mass spectrometry for the quantitative determination of anti‐tuberculosis drugs in milk samples

Development, validation, and measurement uncertainty estimation of automated micro‐solid‐phase extraction coupled with liquid chromatography‐triple quadrupole mass spectrometry for the quantitative determination of anti‐tuberculosis drugs in milk samples

Push forward LC-MS-based therapeutic drug monitoring and pharmacometabolomics for anti-tuberculosis precision dosing and comprehensive clinical management

Infant Exposure to Antituberculosis Drugs via Breast Milk and Assessment of Potential Adverse Effects in Breastfed Infants: Critical Review of Data

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