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

Abdelhay, Mohammad H.; Gazy, Azza A.; Shaalan, Rasha A.; Ashour, Heba K.

doi:10.1155/2013/937409

Cited by 12 publications

(8 citation statements)

References 29 publications

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“…Briefly, fiber samples (3 × 2 cm) were immersed in 30 mL of medium and maintained at 37 • C under shaking conditions (120 rpm). Medium samples (1 mL) were collected at pre-determined time points and replaced with fresh medium, before being assayed by a UV/Vis spectrophotometric derivative method in the range of 200-400 nm [27]. In vitro drug release profiles were fitted to commonly used kinetics models (first order, Korsmeyer-Peppas and Gallagher-Corrigan) using Prism® 5 software (GraphPad Software, La Jolla, CA, USA).…”

Section: Physicochemical Mechanical and Biopharmaceutical Characterization Of Fibersmentioning

confidence: 99%

Electrospun fibers for vaginal administration of tenofovir disoproxil fumarate and emtricitabine in the context of topical pre-exposure prophylaxis

Nunes

Bogas

Faria

et al. 2021

Journal of Controlled Release

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Women are particularly vulnerable to sexual HIV-1 transmission. Oral pre-exposure prophylaxis (PrEP) with tenofovir disoproxil fumarate and emtricitabine (TDF/FTC) is highly effective in avoiding new infections in men, but protection has only been shown to be moderate in women. Such differences have been associated, at least partially, to poor drug penetration of the lower female genital tract and the need for strict adherence to continuous daily oral intake of TDF/FTC. On-demand topical microbicide products could help circumvent these limitations. We developed electrospun fibers based on polycaprolactone (PCL fibers) or liposomes associated to poly(vinyl alcohol) (liposomes-in-PVA fibers) for the vaginal co-delivery of TDF and FTC, and assessed their pharmacokinetics in mice. PCL fibers and liposomes-in-PVA fibers were tested for morphological and physicochemical properties using scanning electron microscopy, differential scanning calorimetry and X-ray diffractometry. Fibers featured organoleptic and mechanical properties compatible with their suitable handling and vaginal administration. Fluorescent quenching of mucin in vitroused as a proxy for mucoadhesionwas intense for PCL fibers, but mild for liposomes-in-PVA fibers. Both fibers were shown safe in vitro and able to rapidly release drug content (15-30 min) under sink conditions. Liposomes-in-PVA fibers allowed increasing genital drug concentrations after a single intravaginal administration when compared to continuous daily treatment for five days with 25-times higher oral doses. For instance, the levels of tenofovir and FTC in vaginal lavage were around 4-and 29-fold higher, respectively. PCL fibers were also superior to oral treatment, although to a minor extent (approximately 2-fold higher drug concentrations in lavage). Vaginal tissue drug levels were generally low for all treatments, while systemic drug exposure was negligible in the case of fibers. These data suggest that proposed fibers may provide an interesting alternative or an ancillary option to oral PrEP in women.

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Section: Physicochemical Mechanical and Biopharmaceutical Characterization Of Fibersmentioning

confidence: 99%

Electrospun fibers for vaginal administration of tenofovir disoproxil fumarate and emtricitabine in the context of topical pre-exposure prophylaxis

Nunes

Bogas

Faria

et al. 2021

Journal of Controlled Release

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“…Literature survey reveals that there are very few ultraviolet (UV) spectrophotometric methods available for the estimation of EMT, TDF, COB, and ELV individually, but there is no UV method for simultaneous estimation of this quad pill. Hence, there is a need to develop and validate a new UV spectrophotometric method for simultaneous estimation of EMT, TDF, COB, and ELV in pure and pharmaceutical dosage form [6][7][8][9][10][11][12][13][14].…”

Section: Harini and Pawarmentioning

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

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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.

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“…TNF was quantified from various active ingredients using HPLC, LC–tandem mass spectrometry (LC–MS/MS; Gollu & Gummadi, 2020; Heydarzadeh et al, 2019; Olejarz et al, 2020; Paritala et al, 2021; Patel et al, 2019; Pavani & Susithra, 2022; Thakare et al, 2023; Xiao et al, 2020; Zhao et al, 2019), spectrophotometry (Buridi, 2013; Ghorpade et al, 2010; Karunakaran et al, 2011), spectrofluorimetry (Tiris et al, 2020), and electrochemical technique (Festinger et al, 2022; Xiao et al, 2022). EMC was analyzed by several techniques, including HPLC (Abdelhay et al, 2015; Haq et al, 2022; Runja et al, 2016), capillary electrophoresis (Guichard et al, 2021), and spectrophotometry (Abdelhay et al, 2013; Ashour & Belal, 2017). BIC was quantified from human plasma using LC–MS/MS (Schauer et al, 2022).…”

Section: Introductionmentioning

confidence: 99%

“…EMC was analyzed by several techniques, including HPLC (Abdelhay et al, 2015;Haq et al, 2022;Runja et al, 2016), capillary electrophoresis (Guichard et al, 2021), and spectrophotometry (Abdelhay et al, 2013;Ashour & Belal, 2017). BIC was quantified from human plasma using LC-MS/MS (Schauer et al, 2022).…”

mentioning

confidence: 99%

A green approach for the analysis of emtricitabine bictegravir and tenofovir in a pharmaceutical preparation using novel HPLC and spectrophotometric methods

Tiris,

Genc,

Oven

et al. 2023

Biomedical Chromatography

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Two spectrophotometric techniques and a novel HPLC method were consecutively applied for the simultaneous quantification of the active ingredients of emtricitabine (EMC), tenofovir (TNF), and bictegravir (BIC). The first spectrophotometric method is the dual amplitude difference method coupled with the ratio difference method. TNF was determined using the dual amplitude difference method, while BIC and EMC were determined using the ratio difference method. The second spectrophotometric method was the constant multiplication with absorbance extraction method, and was applied for the determination of active substances used in the treatment of human immunodeficiency virus (HIV) infection. BIC was determined by the constant multiplication method, whereas EMC and TNF were determined using the absorbance extraction method. For the HPLC method, the XBridge C18 column was used. The solvent system comprised acetonitrile:phosphate buffer (pH 6.8; 30:70 v/v). All active ingredients were detected at 260.0 nm, and the flow rate was 0.5 mL/min. The experiment was completed within 5.5 min. The experiments carried out enabled the simultaneous analysis of the three active substances and they were economical, fast, environmentally friendly, and simple. The methods have been successfully applied to prepare mixtures and tablets without matrix interference. The methods were evaluated in terms of green chemistry. The methods have been validated according to International Council for Harmonisation (ICH) guidelines.

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

Cited by 12 publications

References 29 publications

Electrospun fibers for vaginal administration of tenofovir disoproxil fumarate and emtricitabine in the context of topical pre-exposure prophylaxis

Electrospun fibers for vaginal administration of tenofovir disoproxil fumarate and emtricitabine in the context of topical pre-exposure prophylaxis

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

A green approach for the analysis of emtricitabine bictegravir and tenofovir in a pharmaceutical preparation using novel HPLC and spectrophotometric methods

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