Liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for simultaneous determination of tenofovir and emtricitabine in human plasma and its application to a bioequivalence study

Gomes, Noel A.; Vaidya, Vikas V.; Pudage, Ashutosh; Joshi, Santosh S.; Parekh, Sagar A.

doi:10.1016/j.jpba.2008.07.022

Cited by 75 publications

(55 citation statements)

References 16 publications

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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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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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“…Several HPLC methods were found in the literature for the analysis of TEN-EMT mixture [31][32][33][34]. Detection of both drugs in these methods was achieved either depending on UV-detection [31,33,34] or mass spectrometry [32,35,36].…”

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

confidence: 99%

“…Detection of both drugs in these methods was achieved either depending on UV-detection [31,33,34] or mass spectrometry [32,35,36]. The reported methods were applied for the simultaneous determination of TEN and EMT in plasma [31,32,35,36] or in pharmaceuticals [33,34].…”

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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“…A literature search showed that few methods available for the quantitative determination of dolutegravir 16,17,18,19 , lamivudine 20,21,22 and tenofovir disoproxil fumarate 23 alone, a very few methods available for the quantification of emtricitabine and tenofovir disoproxil tablets 24 , tenofovir disoproxil fumarate, lamivudine, and efavirenz in combined tablet dosage form 25,26 , tenofovir tablets 27 , efavirenz, emtricitabine and tenofovir tablets 28 . But no method has been reported till now for the simultaneous quantitative determination of dolutegravir, lamivudine and tenofovir disoproxil fumarate and its related compounds in fixed finished dosage form by HPLC.…”

Section: Introductionmentioning

confidence: 99%

A Stability-Indicating HPLC Method for the Determination of Potential Impurities in a New Fixed Dose Combination of Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets Used in the First Line Treatment of Hiv-1 Infection

Jagadabi¹,

Kumar²,

Pamidi³

et al. 2018

Int. Res. J. Pharm.

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Developing a single method for the quantification of related compounds for a combination product containing three active ingredients is difficult task. Separation and compromising run time to elute all known and unknown degradation products are crucial for a combination product. The aim of current work is to develop a new stability indicative method and validate for a fixed dose combination product containing dolutegravir, lamivudine, tenofovir disoproxil fumarate and their potential impurities in a single run by HPLC. The critical separation between dolutegravir, lamivudine, tenofovir disoproxil fumarate and its impurities was successfully attained by a new core-shell bi-phenyl, 250x4.6mm, 5µm column with a run time of 150 min. The run time was 150min. Forced degradation studies were verified to prove the stability-indicating nature of the method. Stability-indicating nature was confirmed by peak purity of all the three active components and impurities. The developed method was validated to prove the potentiality of the method as per ICH guidelines with respect to specificity, linearity, accuracy, precision ad robustness. The sensitivity of the method was proved by establishing limit of detection (LOD) and limit of quantification (LOQ) of for dolutegravir, lamivudine, tenofovir disoproxil fumarate and potential impurities.

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Liquid chromatography–tandem mass spectrometry (LC–MS/MS) method for simultaneous determination of tenofovir and emtricitabine in human plasma and its application to a bioequivalence study

Cited by 75 publications

References 16 publications

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

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

A Stability-Indicating HPLC Method for the Determination of Potential Impurities in a New Fixed Dose Combination of Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets Used in the First Line Treatment of Hiv-1 Infection

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