Simultaneous determination of tenofovir alafenamide and tenofovir in human plasma by LC-MS/MS and its application to pharmacokinetics study in clinic

Zhao, Lizhi; Zhou, Li; Zhou, Zhen; Kang, Xiuyuan; Fang, Baihuan; Ma, Huan; Qing-hua, GE

doi:10.1016/j.jchromb.2019.04.011

Cited by 15 publications

(29 citation statements)

References 5 publications

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“…However, SPE is a time‐consuming and expensive procedure. Recently, Zhao et al developed a sensitive LC/MS/MS method using simple PP for the determination of TFV in plasma with a LLOQ of 0.4 ng/mL; however, a large sample volume (200 μL) and injection volume (10 μL) were used . Although it displayed a higher LLOQ of 1 ng/mL, our present study used a lower sample volume (50 μL) and injection volume (2 μL), which helps to reduce contamination of the instrument.…”

Section: Discussionmentioning

confidence: 95%

“…In addition, in most previous research, solid‐phase extraction was used in sample preparation to improve sensitivity, while a few studies were relevant to simple protein precipitation for high sensitivity quantification of TFV . Recently, Zhao et al developed a sensitive LC/MS/MS method for the determination of TFV in plasma with a lower limit of quantification (LLOQ) of 0.4 ng/mL; however, a large sample volume (200 μL) was used, which was 4‐fold greater than that of our study. The rather narrow linear range (0.4–40 ng/mL) in that research might be useful for the analysis of TFV in plasma samples, but it was not suitable for amniotic fluid samples where TFV concentrations exceed 100 ng/mL.…”

Section: Introductionmentioning

confidence: 83%

“…In our pre‐test, TFV exhibited better retention behavior and peak shape in the HSS T3 column than in the BEH C18 column. Therefore, the HSS T3 column was selected in the present study, and also chosen by previous workers . Protein precipitation by MeOH demonstrated good extraction recovery for both TFV and IS (~100%) but resulted in poor peak shape when directed into the LC/MS/MS system.…”

Section: Discussionmentioning

confidence: 99%

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Rapid quantification of tenofovir in umbilical cord plasma and amniotic fluid in hepatitis B mono‐infected pregnant women during labor by ultra‐performance liquid chromatography/tandem mass spectrometry

et al. 2020

Rapid Comm Mass Spectrometry

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Rationale: Tenofovir (TFV) is a first-line antiviral agent against hepatitis B virus (HBV)and is recommended for the prevention of mother-to-infant transmission of HBV. To study the distribution of TFV in umbilical cord plasma and amniotic fluid of HBVinfected pregnant women, a rapid and sensitive method for TFV determination was developed and validated. Methods:The quantification method was developed using liquid chromatography coupled to tandem mass spectrometry (LC/MS/MS). The analytes were separated on an Acquity UPLC HSS T3 column under gradient elution with methanol and 0.01% ammonia solution in 10 mM ammonium acetate/water. This is the first reported method for the determination of TFV using alkaline rather than acidic mobile phases.Linearity, accuracy, precision, limit of quantification, specificity and stability were assessed.Results: Detection of TFV was achieved within 4 min. The calibration curves for TFV quantification showed excellent linearity in the range of 1-500 ng/mL. The intraand interbatch precision and accuracy ranged from −4.35% to 6.92%. This method was successfully applied to determination of samples from 50 HBV mono-infected women undergoing tenofovir disoproxil fumarate therapy. The mean concentrations of TFV in the umbilical cord and amniotic fluid samples were 29.2 (4.6-86) and 470.9 (156-902) ng/mL, respectively, which showed a moderate positive correlation (r = 0.5299, P<0.001). Conclusions:A simple, rapid but sensitive bioanalytical method to determine TFV concentration in both umbilical cord plasma and amniotic fluid using LC/MS/MS was developed and applied to HBV-infected women during labor who were undergoing TDF therapy, which will help us understand the efficacy and safety of tenofovir during pregnancy.

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Section: Discussionmentioning

confidence: 95%

Section: Introductionmentioning

confidence: 83%

Section: Discussionmentioning

confidence: 99%

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Rapid quantification of tenofovir in umbilical cord plasma and amniotic fluid in hepatitis B mono‐infected pregnant women during labor by ultra‐performance liquid chromatography/tandem mass spectrometry

et al. 2020

Rapid Comm Mass Spectrometry

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“…Protein precipitation (PPT) is widely used in biological analysis, especially for high-throughput screening, due to its fast, simple, and cost-efficient characteristics (Feng, Liu, Wang, & Di, 2016;Zhao et al, 2019). Moreover, PPT often provides higher recovery of analytes when compared with solid-phase extraction (SPE) and liquid-liquid extraction (LLE) after optimizing the most appropriate precipitation reagent (Rathod et al, 2017;Wang et al, 2018).…”

Section: Conventional Pretreatment Methodsmentioning

confidence: 99%

Technologies to improve the sensitivity of existing chromatographic methods used for bioanalytical studies

Chen

Gao

Zhong

2020

Biomedical Chromatography

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Chromatographic method has long been recognized as the most widely used separation method in bioanalytical research. However, the relatively low sensitivity of existing chromatographic methods remains a significant challenge, as the requirements for experimental procedures become more demanding. This review discusses the main causes for the low sensitivity of chromatographic methods and aims to introduce different technologies for enhancing their sensitivity in the following aspects: (i) different pretreatment methods for improving clean‐up efficiency and recovery; (ii) derivatization step for altering the chromatographic behavior of analytes and enhancing MS ionization efficiency; (iii) optimal LC–MS conditions and appropriate separation mechanism; and (iv) applications of other chromatographic methods, including miniaturized LC, 2D‐LC, 2D‐GC, and supercritical fluid chromatography. Altogether, this review is devoted to summarizing the recent technologies reported in the literature and providing new strategies for the detection of bioanalytes.

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“…In addition, subjective methods used to measure ART and PrEP adherence, such as self-reported adherence, are prone to social desirability bias; while commonly used objective measures, such as pill counts and pharmacy refill records, are often inaccurate and unreliable [14][15][16]. Objective metrics are available to measure adherence through pharmacokinetic analysis of concentrations of tenofovir (TFV), a drug formulation found in oral PrEP regimens and most ART regimens, which is detectable in whole blood, plasma, dried blood spots, cerebrospinal fluid, mucosal fluid, oral tissue, urine, and hair [12,[17][18][19][20][21][22][23][24][25][26][27][28][29][30]. However, widespread implementation of these metrics is limited by its expense, turnaround time, and need for specialized personnel [23,25].…”

Section: Introductionmentioning

confidence: 99%

Perspectives on the utility and interest in a point-of-care urine tenofovir test for adherence to HIV pre-exposure prophylaxis and antiretroviral therapy: an exploratory qualitative assessment among U.S. clients and providers

et al. 2020

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Background: Real-time, objective measures of adherence to antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are needed to better assess adherence levels and to expedite clinical response for those with suboptimal adherence. Point-of-care tenofovir (POC-TFV) testing has been proposed as a solution to facilitate real-time antiretroviral adherence monitoring, but little is known about how health care providers, people living with HIV (PLWH) receiving ART, and people receiving PrEP will perceive POC-TFV testing. Methods: We conducted an exploratory qualitative study to assess perspectives on the utility and interest in POC-TFV testing from potential end users. We conducted three focus group discussions (FGDs) among 17 PLWH receiving ART and four individuals receiving PrEP, as well as eight in-depth interviews (IDIs) with health care providers in the Seattle area and presented participants with a hypothetical urine-based POC-TFV test. FGDs and IDIs were audio recorded, transcribed, coded, and analyzed to describe emerging themes. Results: Overall, study participants demonstrated divergent opinions about the POC-TFV test. Among study participants, PLWH were most ambivalent about POC-TFV testing, first demonstrating reluctance to TFV-level monitoring and shifting positions during the FGDs. However, all PLWH participants were receptive to POC-TFV testing if requested by their provider. PrEP participants were generally supportive of POC-TFV testing for routine adherence monitoring and emphasized potential value in self-administered testing. Providers' perceptions were equally divided-half suggested POC-TFV testing would be valuable, particularly for people receiving PrEP, while half indicated the test would have little benefit for most individuals receiving ART or PrEP in the U.S. All providers agreed that POC-TFV test results could be beneficial for assessing discrepancies in viral load results and self-reported adherence among PLWH. The study also revealed that a low-cost, non-urine-based POC-TFV test with a long-term limit of detection would be preferred over the hypothetical urine-based test.

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Simultaneous determination of tenofovir alafenamide and tenofovir in human plasma by LC-MS/MS and its application to pharmacokinetics study in clinic

Cited by 15 publications

References 5 publications

Rapid quantification of tenofovir in umbilical cord plasma and amniotic fluid in hepatitis B mono‐infected pregnant women during labor by ultra‐performance liquid chromatography/tandem mass spectrometry

Rapid quantification of tenofovir in umbilical cord plasma and amniotic fluid in hepatitis B mono‐infected pregnant women during labor by ultra‐performance liquid chromatography/tandem mass spectrometry

Technologies to improve the sensitivity of existing chromatographic methods used for bioanalytical studies

Perspectives on the utility and interest in a point-of-care urine tenofovir test for adherence to HIV pre-exposure prophylaxis and antiretroviral therapy: an exploratory qualitative assessment among U.S. clients and providers

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