Relevance of a combined UV and single mass spectrometry detection for the determination of tenofovir in human plasma by HPLC in therapeutic drug monitoring

Barkil, Mirna El; Gagnieu, Marie‐Claude; Guitton, Jérôme

doi:10.1016/j.jchromb.2007.04.015

Cited by 43 publications

(26 citation statements)

References 12 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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“…The literature survey revealed that only few methods are available for the determination of tenofovir in dosage forms and include liquid chromatography with tandem mass spectrometry [4,5]; HPLC with solid phase extraction [6]; reversed phase HPLC [7,8]; HPLC with spectrophotometric detection [9]; HPTLC [10]; gradient ion-pair LC with fluorescent detector [11]; and HPLC-UV, HPLC-MS [12], and first-order UV derivative spectrophotometry [13,14]. Visible spectrophotometry, because of its simplicity, costeffectiveness, sensitivity, selectivity, fair accuracy, and precision, has remained competitive in pharmaceutical analysis.…”

Section: Tenofovir Disoproxil Fumarate (Tdf) 9-[(r)-2-[[bis[(isopropomentioning

confidence: 99%

Extractive Spectrophotometric Determination of Tenofovir Disoproxil Fumarate Using Acidic Triphenylmethane Dyes

Susmitha

Thirumalachary

Singh³

et al. 2014

ISRN Spectroscopy

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Tenofovir disoproxil fumarate is a nucleotide reverse transcriptase inhibitor that has activity against the hepatitis B and HIV viruses. Three simple and sensitive extractive spectrophotometric methods have been described for the assay of tenofovir disoproxil fumarate either in pure form or in pharmaceutical formulations. The developed methods involve formation of colored chloroform extractable ion-pair complexes of the drugs with triphenylmethane dyes, namely, bromothymol blue (BTB), bromophenol blue (BPB), and bromocresol purple (BCP) in acidic medium. The extracted complexes showed absorbance maxima between 410 and 415 nm. Beer's law is obeyed in the concentration ranges 1.5-25, 1.0-25, and 1.25-25 g mL −1 with BTB, BPB, and BCP, respectively. The effectc of concentration of dye, pH, and interference of excipients have been studied and optimized. The limits of detection and quantification have been determined. All three methods are validated as per the guidelines of ICH. The methods have been applied to the determination of drug in commercial tablets and results of analysis were validated statistically through recovery studies.

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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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Relevance of a combined UV and single mass spectrometry detection for the determination of tenofovir in human plasma by HPLC in therapeutic drug monitoring

Cited by 43 publications

References 12 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.

Extractive Spectrophotometric Determination of Tenofovir Disoproxil Fumarate Using Acidic Triphenylmethane Dyes

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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