Simultaneous Method for Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Tablets By HPLC

Gummaluri, R. K.; Parthasarathi, T. V. N.; Anjanamadhulika, G.

doi:10.4172/pharmaceutical-sciences.1000148

Cited by 9 publications

(6 citation statements)

References 6 publications

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“…Various HPLC and HPTLC methods were reported in the literature for the estimation of cobicistat and elvitegravir individually [6][7][8] , simultaneously [9][10] and other antiretroviral drugs [10][11][12][13][14][15][16][17][18][19][20] . The present method is novel and was successfully validated in accordance with ICH guidelines 21 .…”

Section: Fig 2: Chemical Structure Of Elvitegravirmentioning

confidence: 99%

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2019

IJPSR

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A simple, precise, rapid and accurate reverse phase HPLC method was developed for the simultaneous estimation of cobicistat and elvitegravir in the pharmaceutical dosage form. A column of ODS (250mm 4.6mm; i.d and 5µ particle size) was used along with the mobile phase comprising of 0.02M dipotassium hydrogen orthophosphate buffer (pH adjusted to 3.3) and methanol in the ratio of 80:20 (v/v). The flow rate was maintained at 1.0 ml/min and the effluents monitored at 254 nm. The retention time for cobicistat was found to be 2.58 ± 0.3 min and elvitegravir was 3.71 ± 0.3 min. The detection concentration was linear over 125-750 µg/ml for cobicistat and 12.5-75 µg/ml for elvitegravir. Regression equations of cobicistat and elvitegravir were found to be y = 25883x + 19711 and y = 27696x + 6046 respectively with regression coefficient 0.999. The % RSD for Intra and Inter day precision was < 2%. The accuracy of method was validated by recovery studies and found to be significant within acceptable range 98-102%. The developed method was successfully validated in accordance with ICH guidelines. The present study demonstrates the applicability of chromatographic method to develop a new, sensitive, single RP-HPLC method for the simultaneous quantitative determination of cobicistat and elvitegravir in fixed pharmaceutical dosage form. Hence, this method can be conveniently adopted for routine analysis in quality control laboratories.

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Section: Fig 2: Chemical Structure Of Elvitegravirmentioning

confidence: 99%

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2019

IJPSR

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“…Literature survey reveals that HPLC analysis was performed to simultaneously determine multiple drug components in STR-based drug products [9][10][11][12][13][14][15][16][17]. To the best of my knowledge, there were no analytical works for the analysis of STR-based tablets containing DRV, COBI, FTC and TAF.…”

Section: Introductionmentioning

confidence: 99%

Stability-indicating method development and validation for the concurrent determination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide by UPLC in bulk and tablet dosage forms

Sakuntala

Rao²,

Carey³

2021

Futur J Pharm Sci

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Background Tablet dosage forms containing combination of darunavir a protease inhibitor, cobicistat a cytochrome P450 3A inhibitor, emtricitabine and tenofovir alafenamide which were nucleoside reverse transcriptase inhibitors were approved by USFDA on 1st July 2018 to suppress the viral load in HIV patients. It can be used as a complete regimen for the treatment of HIV-1 infection in adults and paediatric patients weighing at least 40 kg. An UPLC method was developed, and separation was done on SB C8 column of dimensions 50 × 2.1 × 1.8 μ with mobile phase 0.01 N potassium dihydrogen ortho phosphate (pH-4.8) and acetonitrile in 60:40 ratio, at a flow rate of 0.3 mL/min and an injection volume of 2 μL. The column temperature was maintained at 30 °C, and detection wavelength was 267 nm. The method was validated according to ICH guidelines. Results The retention times were 1.031, 1.341, 1.630 and 2.153 min, and they were linear in the concentration range of 1.25–7.5 μg/mL, 18.75–112.5 μg/mL, 25–150 μg/mL and 100–600 μg/mL for tenofovir alafenamide, cobicistat, emtricitabine and darunavir, respectively. The intraday and interday precisions were found to be within acceptable limits. LOD was found to be 0.06 μg/mL, 0.51 μg/mL, 1.31 μg/mL and 3.01 μg/mL, and LOQ was 0.19 μg/mL, 1.54 μg/mL, 3.96 μg/mL and 9.13 μg/mL for tenofovir alafenamide, cobicistat, emtricitabine and darunavir. The correlation coefficients were found to be more than 0.999, and recovery was more than 99.52% indicating the method was accurate. Forced degradation studies reveal that the drugs are unstable under acidic conditions. The method was simple, accurate, precise, stable and can be analysed in less runtime of 4 min. Conclusions The flexibility, accuracy and precision of the developed method ensure its applicability in routine analysis of tablet dosage forms. Graphical Abstract

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“…Extensive literature survey revealed a variety of analytical methods for the estimation of ECT in its pure form, the real samples of dosage forms, and biological fluids. Various ultraviolet (UV) spectrometry methods have been proposed for the quantitative analysis of ECT either alone or in combination with other antiviral drugs in pharmaceutical dosage forms. − Several high-performance liquid chromatography (HPLC) techniques have also been used for the quantitative analysis of ECT in its single and combined dosage forms. − The HPLC method has also been reported for the quantitative analysis of ECT in human plasma . Some ultraperformance liquid chromatography (UPLC) methodologies have also been reported for the quantitation of ECT in combined dosage forms. , Several liquid-chromatography tandem mass spectrometry (LC–MS) methodologies have been applied for the quantitative analysis of ECT in combination with other antiviral compounds in human and seminal plasma samples. − Some other techniques like capillary electrophoresis and electrochemical techniques have also been applied for the estimation of ECT in dosage forms. , Several high-performance thin-layer chromatography (HPTLC) techniques have also been used for the quantitative analysis of ECT in its single and combined dosage forms. − However, there is no single study and report on green reversed-phase HPTLC (RP-HPTLC) densitometry analysis of ECT in pharmaceutical dosage forms and biological samples.…”

Section: Introductionmentioning

confidence: 99%

Quantitative Analysis of Emtricitabine in Dosage Forms Using Green RP-HPTLC and Routine NP-HPTLC Methods—A Contrast of Validation Parameters

et al. 2020

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In this research, an antiviral drug emtricitabine (ECT) was quantified using the validated green reversed-phase high-performance thin-layer chromatography (RP-HPTLC) and routine normal-phase HPTLC (NP-HPTLC) methods in the marketed oral solutions and capsules. Green RP-HPTLC-densitometry quantification was performed using the acetone/water (70:30, v/v) solvent system as the mobile phase. Routine NP-HPTLC-densitometry quantification was performed using the chloroform/methanol (85:15, v/v) solvent system as the mobile phase. The detection was performed at λmax285 nm for both of the methods. Both densitometry methods were validated for different parameters. Most of the validation parameters including linearity, precision, accuracy, detection, and quantification limits for the green densitometry method were found to be superior compared to the routine densitometry technique. The ECT contents of commercial oral solution and commercial capsules were found to be 100.85 and 98.27%, respectively, using the green densitometry technique. The ECT contents of oral solutions and capsules were 97.16 and 95.54%, respectively, using the routine densitometry technique. Accordingly, the green densitometry technique was found to be better than the routine densitometry technique for ECT assays. Thus, the green densitometry technique can be successfully applied for the quantitation of ECT in the marketed formulations.

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Simultaneous Method for Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Elvitegravir and Cobicistat in Tablets By HPLC

Cited by 9 publications

References 6 publications

Untitled

Untitled

Stability-indicating method development and validation for the concurrent determination of darunavir, cobicistat, emtricitabine and tenofovir alafenamide by UPLC in bulk and tablet dosage forms

Quantitative Analysis of Emtricitabine in Dosage Forms Using Green RP-HPTLC and Routine NP-HPTLC Methods—A Contrast of Validation Parameters

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