Stability Studies of Rifampicin in Plasma and Urine of Tuberculosis Patients According to the European Medicines Agency Guidelines

Mishra, Pooja; Pawar, Rajendra-Prasad; Bose, Devasish; Durgbanshi, Abhi̧lasha; Albiol-Chiva, Jaume; Péris-Vicente, Juan; Esteve‐Romero, Josep; Jain, Abhishek Kumar

doi:10.4155/bio-2018-0174

Cited by 12 publications

(4 citation statements)

References 36 publications

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“…The absorption peaks do not correspond directly to the absorption peaks of rifampicin when it is dissolved in water. This is likely due to the very high level of protein binding for rifampicin in blood [10] so that, instead, here the absorption peaks correspond to the protein-drug complex. This is supported by the fact that the absorption peaks closely resemble those of whole blood but shifted slightly in frequency.…”

Section: Discussionmentioning

confidence: 97%

Improving tuberculosis treatment using mid-infrared spectroscopy for bedside therapeutic drug monitoring

Rowe

Owens

Nedeljković

et al. 2023

Silicon Photonics XVIII

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Rifampicin is an antimicrobial drug used to treat tuberculosis. The deterioration of a tuberculosis patient on rifampicin is a serious event with several possible causes. Rapid bedside measurement of rifampicin would enable clinicians to determine if patient deterioration was due to subtherapeutic levels and quickly correct the dosing. It would also support personalised dosing to maximise antimicrobial effectiveness whilst minimising side effects. The optimum therapeutic concentration range is 8 -24 mg/L. We report ATR-FTIR spectroscopy data for the detection of rifampicin for bedside therapeutic drug monitoring (TDM). We demonstrate a limit of detection of 0.46 mg/L from 20 μL spiked whole blood samples. Using whole blood directly enables bedside measurements because it does not require centrifugation and pipetting to extract plasma, which are generally performed in a central laboratory. The absorption-concentration response had good linearity (R 2 = 0.998) up to the highest measured concentration of 100 mg/L. We apply this data to the design of a miniaturised mid-infrared sensor for TDM using silicon photonics. We present an analysis of the optimum interaction length for an evanescent waveguide sensor using the absorption of rifampicin and a numerical model to quantify the contributions of different system and device noise sources. These sensors can be made more sensitive than their benchtop equivalent because of the enhanced evanescent electric field strength and the increased power spectral density of tunable quantum cascade lasers.

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Section: Discussionmentioning

confidence: 97%

Improving tuberculosis treatment using mid-infrared spectroscopy for bedside therapeutic drug monitoring

Rowe

Owens

Nedeljković

et al. 2023

Silicon Photonics XVIII

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“…Processed samples were discarded after injection. The specific working procedure required for the HPLC system when using micellar mobile phases was previously reported by Pooja Mishra et al [25].…”

Section: Chromatographic Conditionsmentioning

confidence: 99%

Use of Micellar Liquid Chromatography to Determine Mebendazole in Dairy Products and Breeding Waste from Bovine Animals

et al. 2020

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Mebendazole is an anthelmintic drug used in cattle production. However, residues may occur in produced food and in excretions, jeopardizing population health. A method based on micellar liquid chromatography (MLC) was developed to determine mebendazole in dairy products (milk, cheese, butter, and curd) and nitrogenous waste (urine and dung) from bovine animals. Sample treatment was expedited to simple dilution or solid-to-liquid extraction, followed by filtration and direct injection of the obtained solution. The analyte was resolved from matrix compounds in less than 8 min, using a C18 column and a mobile phase made up of 0.15 M sodium dodecyl sulfate (SDS)-6% 1-pentanol phosphate buffered at pH 7, and running at 1 mL/min under isocratic mode. Detection was performed by absorbance at 292 nm. The procedure was validated according to the guidelines of the EU Commission Decision 2002/657/EC in terms of: specificity, method calibration range (from the limit of quantification to 25-50 ppm), sensitivity (limit of detection 0.1-0.2 ppm; limit of quantification, 0.3-0.6 ppm), trueness (92.5-102.3%), precision (<7.5%, expressed at RSD), robustness, and stability. The method is reliable, sensitive, easy-to-handle, eco-friendly, safe, inexpensive, and provides a high sample-throughput. Therefore, it is useful for routine analysis as a screening or quantification method in a laboratory for drug-residue control.

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“…Current protocols indicate that specimens should be promptly frozen after collection to avoid deterioration; however, in some settings, it is challenging to freeze specimens promptly and keep them frozen while transported [ 4 ]. Furthermore, it is worth noting that RIF undergoes nonenzymatic autooxidation, leading to the formation of rifampicin quinone (RIF-Q), such as in RIF tablets, indicating impurity [ 30 , 31 , 32 ]. In acidic pH, RIF is degraded to 3-formyl-rifampicin (3-F-RIF) [ 33 , 34 ], which becomes more conspicuous in the presence of INH [ 34 ].…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of a UPLC-MS/MS Method for Therapeutic Drug Monitoring, Pharmacokinetic and Stability Studies of First-Line Antituberculosis Drugs in Urine

Abouzid,

Kosicka-Noworzyń,

Karaźniewicz-Łada

et al. 2024

Molecules

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Tuberculosis (TB) remains one of the leading global causes of mortality. Several methods have been established to detect anti-TB agents in human plasma and serum. However, there is a notable absence of studies analyzing TB drugs in urine. Thus, our objective was to validate a method for quantifying first-line anti-TB agents: isoniazid (INH), pyrazinamide (PZA), ethambutol (ETH), and rifampicin (RIF), along with its metabolite 25-desacetylrifampicin, and degradation products: rifampicin quinone and 3-formyl-rifampicin in 10 µL of urine. Chromatographic separation was achieved using a Kinetex Polar C18 analytical column with gradient elution (5 mM ammonium acetate and acetonitrile with 0.1% formic acid). Mass spectrometry detection was carried out using a triple-quadrupole tandem mass spectrometer operating in positive ion mode. The lower limit of quantification (LLOQ) was 0.5 µg/mL for INH, PZA, ETH, and RIF, and 0.1 µg/mL for RIF’s metabolites and degradation products. The method was validated following FDA guidance criteria and successfully applied to the analysis of the studied compounds in urine of TB patients. Additionally, we conducted a stability study of the anti-TB agents under various pH and temperature conditions to mimic the urine collection process in different settings (peripheral clinics or central laboratories).

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Stability Studies of Rifampicin in Plasma and Urine of Tuberculosis Patients According to the European Medicines Agency Guidelines

Cited by 12 publications

References 36 publications

Improving tuberculosis treatment using mid-infrared spectroscopy for bedside therapeutic drug monitoring

Improving tuberculosis treatment using mid-infrared spectroscopy for bedside therapeutic drug monitoring

Use of Micellar Liquid Chromatography to Determine Mebendazole in Dairy Products and Breeding Waste from Bovine Animals

Development and Validation of a UPLC-MS/MS Method for Therapeutic Drug Monitoring, Pharmacokinetic and Stability Studies of First-Line Antituberculosis Drugs in Urine

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