A novel LC‐MS/MS method for simultaneous quantification of tenofovir and lamivudine in human plasma and its application to a pharmacokinetic study

Matta, Murali K.; Burugula, Laxminarayana; Pilli, Nageswara Rao; Inamadugu, Jaswanth Kumar; Jvln, Seshagiri Rao

doi:10.1002/bmc.2679

Cited by 28 publications

(17 citation statements)

References 24 publications

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“…The author'sWang et al, 2013 [7] and Ding et al, 2012 [8] described a LC-MS/MS method for the determination of febuxostat in plasma but both the methods employed protein precipitation (PP) technique for the sample preparation with chromatographic run time of >4 min. An effective bioanalytical method should be simple, sensitive, reproducible, rapid (short analytical run time) and it should require low sample volume for sample processing [9,10] .…”

Section: Introductionmentioning

confidence: 99%

Bioanalysis of Febuxostat in Human Plasma by Liquid Chromatography/Tandem Mass Spectrometry

Kovvasu¹,

Yeung²,

Kunamaneni³

et al. 2018

IJPTR

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Abstract:The objective of this paper was to describe the development and validation of a novel liquid chromatography / tandem mass spectrometry (LC-MS/MS) method for the determination of Febuxostat in human plasma using febuxostat-d9 as internal standard (IS). An API-4000 triple quadrupole mass spectrometer operated in MRM mode was used for the selective quantification of Febuxostat in human plasma. Sample extraction utilizes protein precipitation (PP), followed by analyte and the IS were chromatographed on a C18 column using an isocratic mobile phase composed of 5mM ammonium formate and acetonitrile (20:80, v/v) pumped at a flow rate of 1.0 mL/min. Precision and accuracy of the method was determined using five analytical batches in the concentration range of 15.0-8000 ng/mL. All the validation experiments were carried out as per the US FDA guidelines and results met the acceptance criteria. The developed method was rapid with a total chromatographic run time of 2.0 min.

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Section: Introductionmentioning

confidence: 99%

Bioanalysis of Febuxostat in Human Plasma by Liquid Chromatography/Tandem Mass Spectrometry

Kovvasu¹,

Yeung²,

Kunamaneni³

et al. 2018

IJPTR

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“…Those methods use a large amount of biological samples (0.15-1.0 mL plasma or 2-5 mL urine samples) in order to obtain the high sensitivity or include time-consuming extraction procedures and/or relatively long run time. We adopted the simple and reliable approach for high throughput bioanalysis [14][15][16][17][18] and presented a simple and sensitive method for simultaneous determination of carvedilol and its metabolite in human plasma. This method uses liquid chromatography (LC) combined with tandem mass spectrometry (MS).…”

Section: Introductionmentioning

confidence: 99%

“…This method uses liquid chromatography (LC) combined with tandem mass spectrometry (MS). Samples are prepared using a solid phase extraction technique (SPE) since SPE has its advantageous which were discussed in earlier reports [15][16][17] . This method is useful for characterizing the pharmacokinetics of carvedilol and its metabolite in humans.…”

Section: Introductionmentioning

confidence: 99%

Analysis of Carvedilol and Its Metabolite in Human Plasma Using Liquid Chromatography Coupled with Tandem Mass Spectrometry

Janjanam¹,

Bimireddy²

2017

IJPTR

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: A rapid, sensitive and selective method for the determination of Carvedilol and its metabolite in human plasma was developed using liquid chromatography with tandem mass spectrometry (HPLC-MS/MS). Carvedilol, its metabolite 4-OH carvedilol and abacavir (internal standard) were extracted from human plasma by solid phase extraction technique (SPE) and analyzed on an Discovery column (C8, 50 × 4.6 mm, 5µ) with the mobile phase of acetonitrile -0.1% formic acid in water (70:30 v/v). The analytes were detected using an electro spray ionization tandem mass spectrometry in the multiple reaction monitoring mode. The standard curve was linear (r = 0.9998) over the concentration range of 0.5-100 ng/mL and 0.3-40 ng/mL for carvedilol and 4-OH carvedilol respectively. The lower limit of quantification for carvedilol was 0.5 ng/mL and 0.3 ng/mL for carvedilol and 4-OH carvedilol respectively using 500 µL plasma samples. The coefficient of variation and relative error for intra-and inter-assay at four QC levels were 3.37 to 9.53 %, 4.76 to 7.01% and 3.31 to 6.91%, 5.23 to 6.64 % respectively. The matrix effect for carvedilol, 4-OH carvedilol and abacavir were practically absent. The extraction recoveries of carvedilol, 4-OH carvedilol and abacavir were 78.90, 83.25 and 85.20%, respectively.

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“…Some methods detect tenofovir alone or in combination with other drugs, such as lamivudine [10][11][12] . Two different analytical assays were employed to determine time course plasma drug concentrations in lopinavir-ritonavir and tenofovir drug interaction studies [13][14][15] .…”

mentioning

confidence: 99%

Simultaneous Quantification of Novel Antiretroviral Drug Combination by Stability-indicating High Performance Liquid Chromatography Method

Rao¹,

Sankar²

2016

pharmaceutical-sciences

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Research in the many areas of human immunodeficiency virus treatment, eradication and prevention has necessitated measurement of antiretroviral concentrations in nontraditional specimen types. For HIV infection, drug combinations are typically used as highly active antiretroviral therapy, intended to maximize viral suppression. A novel four drugs combination was used, which contains two nucleoside analog reverse transcriptase inhibitors (lamivudine and tenofovir) and two protease inhibitors (darunavir and ritonavir). A new simple, efficient, and sensitive reverse phase high performance liquid chromatographic method has been developed for simultaneous extraction and determination of the concentrations of lamivudine, tenofovir, darunavir and ritonavir in bulk and in their tablets. Four compounds were separated on a reversed-phase C18 column at 30±2.0° using a gradient mobile phase combination containing potassium dihydrogen phosphate, acetonitrile and methanol. The pH was adjusted to 3.5±0.05 by the addition of orthophosphoric acid. The samples were detected using a UV detector, 260 nm for lamivudine, tenofovir and darunavir and 240 nm for ritonavir. The procedure separated analytes and its potential degradation products such as lamivudine, tenofovir, darunavir and ritonavir eluting at about 2.385, 4.055, 11.353 and 14.010 mins, respectively. The linear range of lamivudine, tenofovir, darunavir and ritonavir was 58.32-174.96 μg/ml, 58.32-174.96 μg/ml, 72.00-216.00 μg/ml and 112.50-337.5 μg/ml, respectively. The relative standard deviation for precision was less than 2.0%. The drug was subjected to acid, alkaline peroxide and photolytic stress conditions and the performance of the method was validated according to the International Conference on Harmonization guidelines for specificity, linearity, accuracy, precision and robustness.

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A novel LC‐MS/MS method for simultaneous quantification of tenofovir and lamivudine in human plasma and its application to a pharmacokinetic study

Cited by 28 publications

References 24 publications

Bioanalysis of Febuxostat in Human Plasma by Liquid Chromatography/Tandem Mass Spectrometry

Bioanalysis of Febuxostat in Human Plasma by Liquid Chromatography/Tandem Mass Spectrometry

Analysis of Carvedilol and Its Metabolite in Human Plasma Using Liquid Chromatography Coupled with Tandem Mass Spectrometry

Simultaneous Quantification of Novel Antiretroviral Drug Combination by Stability-indicating High Performance Liquid Chromatography Method

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