Sensitive assay for determining plasma tenofovir concentrations by LC/MS/MS

Delahunty, Thomas; Bushman, Lane R.; Fletcher, Courtney V.

doi:10.1016/j.jchromb.2005.10.015

Cited by 94 publications

(74 citation statements)

References 9 publications

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“…Literature survey reveals that there are several reports describing the determination of Tenofovir in plasma using HPLC coupled with fluorescence and UV detection [4][5][6][7][8]. Liquid chromatography coupled with tandem mass spectrometry was also reported [9][10][11] , Spectrophotometric [12]. The focus of the present study is to develop and validate a rapid, stable, and economic high performance liquid chromatographic method for quality control of TDF in drug substance form.…”

Section: Fig 1: Chemical Structure Of Tenofovir Disoproxil Fumaratementioning

confidence: 99%

Development and Validation of Rp-Chiral HPLC Method for Quantification of (S)-Isomer in Tenofovir Disoproxil Fumarate

Bodempudi

Rupakula

Reddy

2017

Int J Curr Pharm Sci

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Objective: The main objective of present study was to develop and validate a reverse phase enantioselective chiral high performance liquid chromatographic method was developed for enantiomeric resolution of Tenofovir disoproxil fumarate; it decreases the HIV infection in the human body. The method is specific, rapid, precise and accurate for the separation and determination of (S)-isomer in tenofovir disoproxil fumarate drug substance form. Methods:The S-Isomer of Tenofovir disoproxil fumarate was resolved on a Chiral AGP (150 × 4.0 mm, 5 µm) column (L-41) using a mobile phase system containing 0.1 M ammonium acetate in water pH 6.8 with ammonia solution and methanol in the ratio of (85:15 v/v). The mobile phase was set at a flow rate of 0.8 ml/min and the volume injected was 10μl for every injection. The detection wavelength was set at 260 nm and the column temperature was set at 15 °C. Results:The proposed method was productively applied for the quantitative determination of (S)-isomer in Tenofovir disoproxil fumarate drug substance form. The linear regression analysis data for calibration plots showed a good linear relationship over a concentration range of 0.125 to 3.75 µg/ml for (S)-isomer, 0.125-3.75 µg/ml for Tenofovir disoproxil fumarate. The mean values of the correlation coefficient were 0.999 and 0.999 for (S)-isomer and Tenofovir disoproxil fumarate. The method was validated as per the ICH guidelines. The detection limit (LOD) was about 0.05 µg/ml and quantitation limit (LOQ) was about 0.125 µg/ml for (S)-isomer and Tenofovir disoproxil fumarate. The relative standard deviation was found to be 0.78 % for (S)-isomer in Tenofovir disoproxil fumarate. Conclusion:The developed and validated HPLC method and the statistical analysis showed that the method is repeatable and selective for the estimation of the (S)-isomer of the Tenofovir disoproxil fumarate drug substance.

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Section: Fig 1: Chemical Structure Of Tenofovir Disoproxil Fumaratementioning

confidence: 99%

Development and Validation of Rp-Chiral HPLC Method for Quantification of (S)-Isomer in Tenofovir Disoproxil Fumarate

Bodempudi

Rupakula

Reddy

2017

Int J Curr Pharm Sci

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“…Several HPLC methods are available in the literature for individual drugs and for a combination with other drugs for determination of TDF, FTC, and EFV, but no stability-indicting assay method (SIAM) has been reported. [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27] Few RP-HPLC 28-29 methods are reported for estimation of FTC and TDF in pharmaceutical formulation. The literature survey revealed that there are a very few HPLC and spectroscopic methods available for the determination of Emtricitabine, Tenofovir disoproxil fumarate, Cobicistat, Elvitegravir in pure and combined dosage forms.…”

Section: -9mentioning

confidence: 99%

Development and Validation of Stability-Indicating HPLC-DAD Method for Simultaneous Determination of Emtricitabine, Elvetegravir, Cobicistat and Tenofovir in Their Tablet Dosage Forms.

Rao¹,

Dannana²

2016

IJPER

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A Simple, accurate, specific and rugged reverse phase liquid chromatographic method was developed for the simultaneous estimation of Emtricitabine, Elvetigravir, Cobicistat and Tenofovir in bulk and tablet dosage form. A reverse phase gradient program has been developed to separate the all four active ingredients. The mobile phase consisting of 0.05M Phosphate buffer pH 3.0 (adjusted with dilute phosphoric acid) and Acetonitrile in the ratio 95:5 from 0 min to 4 minutes, further increased the Acetonitrile ratio from 5 to 50 from 4 min to 10 minutes, on a reverse phase C 18 column (250x4.6mm, 5 µ) with a flow rate of 1.0 ml/min, monitored at 240nm. The mean retention times of Emtricitabine, Elvetigravir, Cobicistat and Tenofovir were found to be 1.5, 5.4, 6.6 and 7.5 min respectively. The proposed method was validated in terms of Linearity, Range, Accuracy, Precision, Specificity, Robustness and Ruggedness and the method was successfully applied for the estimation of Emtricitabine, Elvetigravir, Cobicistat and Tenofovir in combined tablet dosage form.

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“…High-performance liquid chromatography (HPLC) finds great application in the therapeutic drug monitoring of TEN in different biological samples [13][14][15][16][17][18][19]. Almost all HPLC assays depend on mass spectrometric detection of TEN.…”

Section: Fig 1 Structures Of Tenofovir Disproxyl Fumarate (Ten) Andmentioning

confidence: 99%

Selective RP-HPLC DAD method for determination of tenofovir fumarate and emtricitabine in bulk powder and in tablets

Abdelhay¹,

Gazy²,

Shaalan³

et al. 2015

Acta Chromatographica

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Summary.A simple and selective liquid chromatographic method was developed for the simultaneous determination of tenofovir disoproxil fumarate (TEN) and emtricitabine (EMT) in combined tablets. The method is based on separation of TEN and EMT on a Zorbax SB-C8 column, 5 μm, 4.6 × 250 mm, with a mobile phase consisting of 50 mM disodium hydrogen phosphate-acetonitrile (50:50, v/v). The mobile phase contains 0.1% triethylamine (TEA) and was adjusted to pH 6.0. Quantification of the analytes is achieved with diode array -ultraviolet detector (DAD-UV) at 260 and 280 nm for TEN and EMT, respectively, based on peak area. Different variables affecting the method were carefully investigated and optimized. Reliability and analytical performance of the proposed method, including linearity, range, precision, accuracy, and detection and quantitation limits, were statistically validated. The high-performance liquid chromatography (HPLC) method was successfully applied for determination of each drug in their binary tablets.

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Sensitive assay for determining plasma tenofovir concentrations by LC/MS/MS

Cited by 94 publications

References 9 publications

Development and Validation of Rp-Chiral HPLC Method for Quantification of (S)-Isomer in Tenofovir Disoproxil Fumarate

Development and Validation of Rp-Chiral HPLC Method for Quantification of (S)-Isomer in Tenofovir Disoproxil Fumarate

Development and Validation of Stability-Indicating HPLC-DAD Method for Simultaneous Determination of Emtricitabine, Elvetegravir, Cobicistat and Tenofovir in Their Tablet Dosage Forms.

Selective RP-HPLC DAD method for determination of tenofovir fumarate and emtricitabine in bulk powder and in tablets

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