Method for simultaneous analysis of nine second-line anti-tuberculosis drugs using UPLC-MS/MS

Han, Minje; Jun, Sun Hee; Lee, Jae Ho; Park, Kyoung Un; Song, Junghan; Song, Sang Hoon

doi:10.1093/jac/dkt154

Cited by 42 publications

(39 citation statements)

References 29 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Serial blood samples were collected in heparin-containing tubes at 0 (i.e., predosing), 0.5, 1, 1.5, 2, 2.5, 3,4,6,8,12, and 24 h after dosing on day 5. Blood samples were centrifuged for 10 min at approximately 1,910 ϫ g at 4°C.…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Pharmacokinetics of Second-Line Antituberculosis Drugs after Multiple Administrations in Healthy Volunteers

Park

Jang

et al. 2015

Antimicrob Agents Chemother

View full text Add to dashboard Cite

dTherapeutic drug monitoring (TDM) of second-line antituberculosis drugs would allow for optimal individualized dosage adjustments and improve drug safety and therapeutic outcomes. To evaluate the pharmacokinetic (PK) characteristics of clinically relevant, multidrug treatment regimens and to improve the feasibility of TDM, we conducted an open-label, multiple-dosing study with 16 healthy subjects who were divided into two groups. Cycloserine (250 mg), p-aminosalicylic acid (PAS) (5.28 g), and prothionamide (250 mg) twice daily and pyrazinamide (1,500 mg) once daily were administered to both groups. Additionally, levofloxacin (750 mg) and streptomycin (1 g) once daily were administered to group 1 and moxifloxacin (400 mg) and kanamycin (1 g) once daily were administered to group 2. Blood samples for PK analysis were collected up to 24 h following the 5 days of drug administration. The PK parameters, including the maximum plasma concentration (C max ) and the area under the plasma concentration-time curve during a dosing interval at steady state (AUC ), were evaluated. The correlations between the PK parameters and the concentrations at each time point were analyzed. The mean C max and AUC , respectively, for each drug were as follows: cycloserine, 24.9 mg/liter and 242.

show abstract

Section: Methodsmentioning

confidence: 99%

“…This analytical method was developed previously for simultaneous measurement of the blood concentrations of nine second-line anti-TB drugs (6). In brief, the analytes were separated on a high-strength silica (HSS) T3 column (50.0 by 2.1 mm, 1.8-m particles; Waters, Watford, United Kingdom) at a flow rate of 200 l/min.…”

Section: Methodsmentioning

confidence: 99%

Pharmacokinetics of Second-Line Antituberculosis Drugs after Multiple Administrations in Healthy Volunteers

Park

Jang

et al. 2015

Antimicrob Agents Chemother

View full text Add to dashboard Cite

show abstract

“…In addition, no matrix effects due to hemolytic, lipemic, or icteric plasma matrices were observed. Multiple methods for the quantification of kanamycin have been published (8,9,11,(22)(23)(24)(25). Only one paper describes the use of an immunoassay for the determination of kanamycin where a tobramycin antibody was used as well (23).…”

Section: Discussionmentioning

confidence: 99%

“…A high-pressure liquid chromatography method has a rather high LLOQ, 3 mg/liter (24), and inaccuracy and imprecision determinations according to EMA or FDA guidelines were not reported (15,26). In addition, three LC-MS/MS methods are available, but these methods require expensive technology and experienced laboratory personnel (8,9,11).…”

Section: Discussionmentioning

confidence: 99%

Immunoassay Analysis of Kanamycin in Serum Using the Tobramycin Kit

Dijkstra

Voerman

Greijdanus

et al. 2016

Antimicrob Agents Chemother

View full text Add to dashboard Cite

bKanamycin is one of the aminoglycosides used in the treatment of multidrug-resistant tuberculosis. Blood concentrations of kanamycin are predictive for the treatment efficacy and the occurrence of side effects, and dose adjustments can be needed to optimize therapy. However, an immunoassay method for the quantification of kanamycin is not commercially available. We modified the existing tobramycin immunoassay to analyze kanamycin. This modified method was tested in a concentration range of 0.3 to 80.0 mg/liter for inaccuracy and imprecision. In addition, the analytical results of the immunoassay method were compared to those obtained by a liquid chromatography-tandem mass spectrometry (LC-MS/MS) analytical method using Passing and Bablok regression. Within-day imprecision varied from 2.3 to 13.3%, and between-day imprecision ranged from 0.0 to 11.3%. The inaccuracy ranged from ؊5.2 to 7.6%. No significant cross-reactivity with other antimicrobials and antiviral agents was observed. The results of the modified immunoassay method were comparable with the LC-MS/MS analytical outcome. This new immunoassay method enables laboratories to perform therapeutic drug monitoring of kanamycin without the need for complex and expensive LC-MS/MS equipment.T uberculosis (TB) is an infectious disease caused by Mycobacterium tuberculosis. Unfortunately, resistance to the two firstline drugs in TB treatment, isoniazid and rifampin, is emerging (1). Treatment regimens for multidrug-resistant TB (MDR-TB) include a quinolone and an injectable: amikacin, kanamycin, or capreomycin (2). Unfortunately, the use of aminoglycosides comes with toxic effects, such as renal failure and irreversible hearing loss (3).Recently, a study with MDR-TB patients showed that the toxicity of aminoglycosides was correlated with the cumulative area under the curve (4). For efficacy, it is well recognized that the top serum concentration (C max ) is related to the efficacy of aminoglycosides (5). In addition, pharmacokinetic (PK) guided dosing reduced the daily dose of aminoglycosides, with excellent treatment outcome (6). This indicates that serum concentration monitoring may be of added value in the treatment of tuberculosis. The targeted peak concentration for kanamycin in MDR-TB is 20 to 30 mg/liter (7), while the trough concentration should be as low as reasonably achievable in order to prevent toxicity.Although analytical methods to quantify the serum or plasma concentrations of amikacin and kanamycin using liquid chromatography-tandem mass spectrometry (LC-MS/MS) (8-11) have been described, this technique is commonly not available in most developing countries (12). However, in contrast to the case for amikacin, no analytical immunoassay kit to analyze kanamycin is commercially available.Kanamycin is more structurally related to tobramycin than to amikacin (Fig. 1). The product insert of the tobramycin immunoassay kit, based on the enzyme multiplied immunoassay technique (EMIT), indicates cross-reactivity for kanamycin (13). We therefore explored the...

show abstract

“…[105] This would reduce analyzing time and would provide an easier method. This seems to be a possibility looking at the study of Han et al, [106] but this need to be validated for DBS.…”

Section: Dbsmentioning

confidence: 99%

Current status and opportunities for therapeutic drug monitoring in the treatment of tuberculosis

Zuur

Bolhuis

Anthony

et al. 2016

Expert Opinion on Drug Metabolism & Toxicology

View full text Add to dashboard Cite

Introduction: Tuberculosis remains a global health problem and pharmacokinetic variability has been postulated as one of the causes of treatment failure and acquired drug resistance. New developments enable implementation of therapeutic drug monitoring, a strategy to evaluate drug exposure in order to tailor the dose to the individual patient, in tuberculosis treatment. Areas covered: Literature on pharmacokinetics and pharmacodynamics of anti-tuberculosis drugs was explored to evaluate the effect of drug exposure in relation to drug susceptibility, toxicity and efficacy. New, down-sized strategies, like dried blood spot analysis and limited sampling strategies are reviewed. In addition, molecular resistance testing of Mycobacteria tuberculosis, combining a short turn-around time with relevant information on drug susceptibility of the causative pathogen was explored. Newly emerging host biomarkers provide information on the response to treatment. Expert opinion: Therapeutic drug monitoring can minimize toxicity and increase efficacy of tuberculosis treatment and prevent the development of resistance. Dried blood spot analysis and limited sampling strategies, can be combined to provide us with a more patient friendly approach. Furthermore, rapid information on drug susceptibility by molecular testing, and information from host biomarkers on the bacteriological response, can be used to further optimize tuberculosis treatment. ARTICLE HISTORY

show abstract

Method for simultaneous analysis of nine second-line anti-tuberculosis drugs using UPLC-MS/MS

Cited by 42 publications

References 29 publications

Pharmacokinetics of Second-Line Antituberculosis Drugs after Multiple Administrations in Healthy Volunteers

Pharmacokinetics of Second-Line Antituberculosis Drugs after Multiple Administrations in Healthy Volunteers

Immunoassay Analysis of Kanamycin in Serum Using the Tobramycin Kit

Current status and opportunities for therapeutic drug monitoring in the treatment of tuberculosis

Contact Info

Product

Resources

About