A validated method for development of tenofovir as API and tablet dosage forms by UV spectroscopy

Gnanarajan, G.; Gupta, Abhay; Juyal,; Kumar, Pramod; Yadav, Pawan Kumar; Kailash, P

doi:10.4103/0975-1483.59326

Cited by 13 publications

(6 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The method was validated according to International Conference on Harmonization (ICH) guidelines to determine the linearity, limit of detection (LOD), limit of quantification (LOQ), precision, accuracy, ruggedness, and robustness of the method [17][18][19][20][21][22][23][24].…”

Section: Validation Of Developed Methodsmentioning

confidence: 99%

Development and Validation of Stability Indicating Simultaneous Uvspectrophotometric Method for Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Cobicistat, and Elvitegravir in Pure and Pharmaceutical Dosage Form

Akm

2018

Asian J Pharm Clin Res

View full text Add to dashboard Cite

Objective: The objective of this research work was to develop and validate a simple, precise, and accurate new ultraviolet-spectrophotometric method for the simultaneous estimation of emtricitabine (EMT), tenofovir disoproxil fumarate (TDF), cobicistat (COB), and elvitegravir (ELV) in pure and pharmaceutical marketed dosage form (stribild).Methods: Simultaneous equation method (Vierordt’s method) was developed for simultaneous determination of several mixtures containing two or more absorbing drugs (p, q, r, and s) each of which absorbs at the λ max of the other. Forced degradation studies were also conducted, and the drugs were subjected to various stress conditions such as acid hydrolysis, base hydrolysis, oxidative, photolytic, and thermal degradation.Results: The λ max of EMT, ten TDF, COB, and ELV are 283 nm, 259 nm, 240 nm, and 258 nm, respectively. The linearity ranges for the four drugs are EMT (4–24 μg/ml), TDF (10–50 μg/ml), COB (10–120 μg/ml), and ELV (2–10 μg/ml).Conclusion: The Vierordt’s method was successfully applied for simultaneous determination of EMT, TDF, COB, and ELV in a mixture of sample solution (pharmaceutical dosage form) and the results obtained were validated and found to be accurate, precise, linear, rugged, and robust.

show abstract

Section: Validation Of Developed Methodsmentioning

confidence: 99%

Development and Validation of Stability Indicating Simultaneous Uvspectrophotometric Method for Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Cobicistat, and Elvitegravir in Pure and Pharmaceutical Dosage Form

Akm

2018

Asian J Pharm Clin Res

View full text Add to dashboard Cite

show abstract

“…Tenofovir alafenamide fumarate is a prodrug of Tenofovir prepared by reacting one mole of fumaric acid with two moles of tenofovir alafenamide. The IUPAC name of TAF is [2][3][4][5][6][7][8]. Along with the individual methods, analytical and bio analytical methods were available in simultaneous estimation in combination with other antiviral drugs [9,10].…”

Section: Introductionmentioning

confidence: 99%

RP-HPLC Method for Quantification of Emtricitabine and Tenofovir Alafenamide Fumarate Drug Substance and Tablet Dosage Form

Sarat

Ramachandran

2021

JPRI

View full text Add to dashboard Cite

Aim: The primary objective of the research work is to develop a effective, sensitive, economical and simple reverse phase HPLC method to estimate Emtricitabine and tenofovir alafenamide fumarate in its pure and binary mixture of tablets. Study Design: HPLC based Quantification Studies. Place and Duration of Study: 1Department of Chemistry, Acharya Nagarjuna University,Guntur, Andhra Pradesh between April 2019 and August 2020. Methodology: Separation of the analytes were done by using Eclipse XDB-Phenyl (250 x 4.6mm, 5µ,100 A0) column and a mobile phase ratio of 30:10:70 percentage of 0.1% trifluoro acetic acid: acetonitile: methanol at a flow rate of 1 ml/min. The injected standard and sample solutions were detected 260nm wavelength. Results: The retention time of Emtricitabine and tenofovir alafenamide fumarate were found at 2.3min and 2.8 min respectively. The method has good linearity range about 50 to 150µg/ml of Emtricitabine and 6.5 to 19.5 µg/ml of tenofovir alafenamide fumarate. The method has validated as per ICH guidelines and all the validation parameterwere satisfy the ICH Q2 specification acceptance limits Conclusion: The developed method said to be highly sensitive, accurate, specific and robust, therefore this method has high probability to adopt in pharmaceutical industry for regular analysis of Emtricitabine and tenofovir alafenamide.

show abstract

“…Simple spectrophotometric techniques have been published involving determination of TEN by direct methods [4,5], derivative calculation [6][7][8]. Other spectrophotometric methods published include colorimetric assay using various derivatizing reagents [9][10][11][12].…”

Section: Introductionmentioning

confidence: 99%

Simple Spectrophotometric Methods for Determination of Tenofovir Fumarate and Emtricitabine in Bulk Powder and in Tablets

Abdelhay

Gazy

Shaalan

et al. 2013

Journal of Spectroscopy

View full text Add to dashboard Cite

Two simple and selective methods were developed for the simultaneous determination of tenofovir fumarate (TEN) and emtricitabine (EMT) in combined tablets. The first method involves the application of first derivative spectrophotometry where the first derivative amplitudes were measured at 298.5 nm for determination of EMT in presence of TEN. The second method involves first derivative of ratio spectra spectrophotometry where the amplitudes at 251.5 nm have been used for quantitation of TEN in the presence of EMT. Different variables affecting each method were carefully investigated and optimized. Reliability and analytical performance of the proposed methods, including linearity, range, precision, accuracy, detection, and quantitation limits, were statistically validated. The methods were successfully applied for the determination of EMT and TEN in laboratory-prepared mixtures and in their combined tablets.

show abstract

A validated method for development of tenofovir as API and tablet dosage forms by UV spectroscopy

Cited by 13 publications

References 3 publications

Development and Validation of Stability Indicating Simultaneous Uvspectrophotometric Method for Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Cobicistat, and Elvitegravir in Pure and Pharmaceutical Dosage Form

Development and Validation of Stability Indicating Simultaneous Uvspectrophotometric Method for Determination of Emtricitabine, Tenofovir Disoproxil Fumarate, Cobicistat, and Elvitegravir in Pure and Pharmaceutical Dosage Form

RP-HPLC Method for Quantification of Emtricitabine and Tenofovir Alafenamide Fumarate Drug Substance and Tablet Dosage Form

Simple Spectrophotometric Methods for Determination of Tenofovir Fumarate and Emtricitabine in Bulk Powder and in Tablets

Contact Info

Product

Resources

About