Sensitive determination of tenofovir in human plasma samples using reversed-phase liquid chromatography

Sentenac, Sabine; Fernandez, Christine; Thuillier, A.; Lechat, Philippe; Aymard, Guy

doi:10.1016/s1570-0232(03)00333-7

Cited by 64 publications

(54 citation statements)

References 5 publications

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“…For the LC method development, the Rezk et al [5] and Sentenac et al [4] methods were used as starting point. Both methods were described for the determination of tenofovir in human plasma.…”

Section: Methods Developmentmentioning

confidence: 99%

“…Some LC methods with different detection systems have been described for the quantitative determination of tenofovir in human plasma, such as LC with spectrofluorimetric detection [3], LC with photodiode array detection (DAD) [4,5] and LC with mass spectrometric (MS) detection [6,7]. After our study was started already, a gradient LC method for purity control and an isocratic LC method for the assay of TDF were published in the Indian pharmacopoeia (IP) [1].…”

Section: Introductionmentioning

confidence: 99%

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Development of a validated liquid chromatographic method for the determination of related substances and assay of tenofovir disoproxil fumarate

Ashenafi

Chintam

Veghel

et al. 2010

J of Separation Science

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Development of a validated liquid chromatographic method for the determination of related substances and assay of tenofovir disoproxil fumarateThe present study describes the development and validation of a selective liquid chromatographic (LC) method for the analysis of tenofovir disoproxil fumarate (TDF) and its related substances. The gradient method uses a base deactivated C18 column (Hypersil BDS column; 25 cm Â 4.6 mm I.D.) maintained at a temperature of 301C. The mobile phases consist of acetonitrile, tetrabutylammonium/phosphate buffer pH 6.0 and water: (A; 2:20:78 v/v/v) and (B; 65:20:15 v/v/v). The flow rate is 1.0 mL/min and UV detection is performed at 260 nm. Good separation of TDF and 21 impurities was achieved. A system suitability test (SST) to check the quality of separation is also specified. The developed method was further validated with respect to robustness, precision, sensitivity and linearity. The method is proved to be robust, precise, sensitive and linear between 0.1 mg/mL and 0.15 mg/mL. The limit of detection and limit of quantification are 0.03 and 0.1 mg/ mL, respectively. The method was successfully applied to the quantification of related substances and assay of commercial TDF samples (bulk substances and tablets).

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Section: Methods Developmentmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development of a validated liquid chromatographic method for the determination of related substances and assay of tenofovir disoproxil fumarate

Ashenafi

Chintam

Veghel

et al. 2010

J of Separation Science

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“…TDF remains in cells for longer periods of time than many other antiretroviral drugs, thereby allowing for once-daily dosing. 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].…”

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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“…Standard stock solution of tenofovir (2 mg mL −1 ) was prepared by dissolving 10.6 mg of tenofovir monohydrate (molecular weight 305.23 g mol −1 ) in 5 mL of Milli-Q grade water containing 75 μL of 5 M sodium hydroxide solution [14,15]. The working standard solutions of tenofovir were prepared by making appropriate dilutions of the aliquots of the standard solution with pH 4 ammonium acetate buffer.…”

Section: Preparation Of Standard Stock and Working Standard Solutionsmentioning

confidence: 99%

“…Table I compares the current analytical technique with existing liquid chromatographic methods. Analytical methods were developed using high-performance liquid chromatography (HPLC) with ultraviolet (UV) detector [14][15][16], fluorescence detector [17][18], mass spectrophotometer [19][20], and tandem mass spectrophotometer (MS-MS) [21][22][23][24][25][26]. Almost all the reported methods were meant for the analysis of tenofovir in human plasma; only one study by V. Bezy et al was reported for the analysis of tenofovir in rat plasma [16].…”

Section: Introductionmentioning

confidence: 99%

A Simple Liquid Chromatographic Method for the Determination of Tenofovir in Rat Plasma and Its Application to Pharmacokinetic Studies

Ravi

Joseph

Avula

et al. 2015

Acta Chromatographica

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Summary. The objective of this study was to develop and validate a novel, simple, and selective high-performance liquid chromatographic (HPLC) method with photodiode array detector for the estimation of tenofovir in rat plasma, which can be utilized in analyzing the pharmacokinetic samples from rats. Prior to analysis, an optimized protein precipitation technique was used to extract tenofovir from plasma. The mobile phase for this method comprised of 10 mM ammonium acetate buffer (pH 4) and methanol in the ratio of 97:3 v/v. Chromatographic separation of tenofovir was achieved using Spincotech C-18G enabled column (250 × 4.6 mm, 5 μm). Tenofovir was monitored at a wavelength of 260 nm, and the calibration curve was linear in the range of 250-4000 ng mL −1 (R 2 = 0.999). High recovery obtained after extraction (97%-101%) of plasma samples precluded the use of an internal standard. Validation studies were performed as per the standard guidelines, and the developed method was accurate, precise, and selective for the determination of tenofovir in the rat plasma. The stability studies performed during the sample pretreatment process and sample storage conditions did not show a quantifiable degradation of tenofovir. Further, this method was able to estimate tenofovir and determine its pharmacokinetic parameters, post IV bolus administration in male Wistar rats. The pharmacokinetic profile of tenofovir followed one compartmental open model.

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Sensitive determination of tenofovir in human plasma samples using reversed-phase liquid chromatography

Cited by 64 publications

References 5 publications

Development of a validated liquid chromatographic method for the determination of related substances and assay of tenofovir disoproxil fumarate

Development of a validated liquid chromatographic method for the determination of related substances and assay of tenofovir disoproxil fumarate

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

A Simple Liquid Chromatographic Method for the Determination of Tenofovir in Rat Plasma and Its Application to Pharmacokinetic Studies

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