A validated LC–MS/MS method for the simultaneous determination of BMS-791325, a hepatitis C virus NS5B RNA polymerase inhibitor, and its metabolite in plasma

Yuan, Long; Jiang, Hao; Zheng, Naiyu; Xia, Yuanqing; Ouyang, Zheng; Zeng, Jianing; Akinsanya, Billy; Valentine, J L; Moehlenkamp, Jeffrey D.; Deng, Yuzhong; Aubry, Anne‐Françoise; Arnold, Mark E.

doi:10.1016/j.jchromb.2014.10.005

Cited by 20 publications

(4 citation statements)

References 11 publications

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“…5 ), which suggested that several potential biomarkers in the urine were clearly altered in the KOA group when compared with the control group. Loading plots revealed the distribution of variables and identified differences in the compound present in the samples or groups based on those variables ( 18 ). Each dot in the loading plot represented a metabolite and the dots near the center indicated smaller differences between the groups than those shown by dots far away from the center.…”

Section: Resultsmentioning

confidence: 99%

Gas chromatography‑time of flight/mass spectrometry‑based metabonomics of changes in the urinary metabolic profile in osteoarthritic rats

et al. 2018

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The aim of the present study was to explore changes in the urinary metabolic spectrum in rats with knee osteoarthritis, using gas chromatography-time of flight/mass spectrometry (GC-TOF/MS) to determine the metabonomic disease pathogenesis. Sprague-Dawley rats were randomly divided into the control and model groups (n=8/group), and 20 µl of 4% papain and 0.03 M L-cysteine was injected into the right knee on days 1, 3 and 7 to establish the knee osteoarthritis model. Following 14 days, urine was collected over 12 h and cartilage ultrastructural damage was assessed by hematoxylin-eosin staining. GC-TOF/MS, combined with principal component analysis, partial least squares discriminant modeling and orthogonal partial least squares discriminant modeling, was used to analyze the changes in the metabolic spectrum trajectory and to identify potential biomarkers and their related metabolic pathways. Compared with the control group, the synovial cell lining of the knee joint exhibited proliferation, inflammatory cell infiltration and collagen fiber hyperplasia in the knee osteoarthritis group. A total of 23 potential biomarkers were identified, including alanine, α-ketoglutarate, asparagine, maltose and glutamine. Furthermore, metabolomic pathogenesis of osteoarthritis may be related to disorders of amino acid metabolism, energy metabolism, fatty acid metabolism, vitamin B6 metabolism and nucleic acid metabolism.

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Section: Resultsmentioning

confidence: 99%

Gas chromatography‑time of flight/mass spectrometry‑based metabonomics of changes in the urinary metabolic profile in osteoarthritic rats

et al. 2018

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“…This study describes a validated spectrofluorimetric method for the quantitative detection of DCV in its pure form, and which is commercially available in tablet form and in human plasma samples that were collected from HCV patients treated with DCV. This method was almost a thousand times more sensitive than the previously reported HPLC methods [14][15][16] and with a comparable sensitivity to the reported LC/MS/MS methods [12][13]. The study was analytically validated according to the FDA guidelines and was extended to investigate the stability/degradation process of DCV under various stress conditions.…”

Section: Introductionmentioning

confidence: 84%

“…Many methods have been reported for the detection of DCV, in tablets or biological fluids, including UPLC/ MS/MS [9][10][11], LC/MS/MS [12,13], HPLC [14][15][16], and electrochemical method [17]. However, the application of such methods for the analysis of DCV in low socioeconomic countries, where HCV is an epidemic, is limited due to the high cost of operations and the rare availability of equipment.…”

Section: Introductionmentioning

confidence: 99%

Specific, highly sensitive and simple spectrofluorimetric method for quantification of daclatasvir in HCV human plasma patients and in tablets dosage form

Ali

Elsutohy

2019

Open Chemistry

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A simple, selective and highly sensitive spectrofluorimetric method for the quantitative detection of an antiviral drug, daclatasvir (DCV) has been developed and analytically validated in its pure form, in its commercially available pharmaceutical preparations, and in hepatitis-C (HCV) patient’s plasma. The method was based on recording the native fluorescence of DCV that exhibit an emission wavelength maximum at 380 nm upon excitation at 320 nm. Many factors affecting the fluorescence intensity and the method sensitivity including pH, type of surfactant and solvent have been studied and optimized. In addition, a stability-indicating study was performed in accordance with the guidelines of the International Conference on Harmonization (ICH), to detect the drug in the presence of its degradation products which validates the method for application in quality control laboratories. In addition, extraction of DCV from the plasma proteins was performed using a simple technique that was based on using methanol and borate buffer (pH 9) that gave a recovery of ~95%. The results showed that DCV could be detected using this method in the pure form (with a linear range of 2-1000 ng/mL), commercially available tablets and in plasma samples (with a linear range of 5-1000 ng/mL), without any interferences. Furthermore, the method was also analytically and clinically validated according to the Food and Drug Administration (FDA) guidelines, with limit of detection (LOD) of 0.3 and 0.5 ng/mL for DCV in the pure form and plasma samples, respectively.

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“…A systematic method screening and optimization approach [6][7][8][9] was used to optimize the mass spectrometry, chromatography, and sample extraction conditions for the LC-MS/MS assay. Briefly, four aqueous mobile phases from acidic to basic and a total of 11 different UHPLC columns (C18, modified C18, phenyl and other types from several different manufacturers) were screened to achieve the best chromatographic separation and sensitivity.…”

Section: Methods Developmentmentioning

confidence: 99%

A UHPLC–MS/MS bioanalytical assay for the determination of BMS-911543, a JAK2 inhibitor, in human plasma

Liu

Yuan

et al. 2015

Journal of Chromatography B

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A validated LC–MS/MS method for the simultaneous determination of BMS-791325, a hepatitis C virus NS5B RNA polymerase inhibitor, and its metabolite in plasma

Cited by 20 publications

References 11 publications

Gas chromatography‑time of flight/mass spectrometry‑based metabonomics of changes in the urinary metabolic profile in osteoarthritic rats

Gas chromatography‑time of flight/mass spectrometry‑based metabonomics of changes in the urinary metabolic profile in osteoarthritic rats

Specific, highly sensitive and simple spectrofluorimetric method for quantification of daclatasvir in HCV human plasma patients and in tablets dosage form

A UHPLC–MS/MS bioanalytical assay for the determination of BMS-911543, a JAK2 inhibitor, in human plasma

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