A Validated Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Tenofovir, Emtricitabine, and a Efavirenz and Statistical Approach to Determine the Effect of Variables

Devrukhakar, Prashant S.; Borkar, Roshan M.; Shastri, Nalini R.; Surendranath, K. V.

doi:10.1155/2013/878295

Cited by 20 publications

(11 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Wavelength of maximum absorption for 10 µg/mL solution of the bulk drug in methanol was scanned using UV-Visible spectrophotometer within the range of 200-400 nm wavelength with methanol as reference. The absorption curve shows at 228 nm for atenolol formulation [11][12][13][14][15][16] .…”

Section: Determination Of Working Wavelength (λMax)mentioning

confidence: 99%

Formulation, Development and Evaluation of Fast Dissolving Oral Film of a Atenolol Drug and validation by RP-HPLC Method using ICH Q2 guidelines

Khandare

Wagh²

2019

J. Drug Delivery Ther.

View full text Add to dashboard Cite

Now a days, fast dissolving dosage forms are gaining popularity, as this dosage form can be administered without water. Rapid dissolving property, avoiding first pass metabolism and majority of the drug is absorbed through buccal/oral mucosa in to systemic circulation. On oral administration of atenolol undergoes first pass metabolism results in reduced bioavailability up to (60%), so the objective of the present study was to formulate and evaluate fast dissolving oral films of atenolol to overcome the limitation of bioavailability and increase patient’s compliance. In recent studies oral films were prepared by solvent casting method using HPMC K15 as a film formers and PEG 400, glycerin as plasticizers and evaluated for mechanical properties, disintegration and in vitro dissolution. Good mechanical properties and in vitro drug release were shown by all formulations. The Comparing to other formulations, the optimized (F5) Formulation (HPMC K15, CCS and PEG 400) Exhibited drug release of 92.12% in 15 minutes which was significantly high. RP-HPLC is simple, fast, precise, sensitive, and reproducible (liquid chromatography) method was developed and validated for the analysis of atenolol drug formulation. Using C-18 HPLC column separation was carried out. This was maintained at ambient temperature. Analysis was carried out by using UV detector at the wavelength 228 nm. The RP-HPLC method was found to be linear over the concentration ranges from 50-100 μg/mL (r2 =0.999). Retention time for atenolol drug formulation was found to be 5.496min. LOQ of method was 5.7308μg/mL and LOD 2.5036μg/mL. Keywords: Atenolol, Fast dissolving oral film, Bioavailability, Mechanical properties, C18, RP-HPLC, Methanol

show abstract

Section: Determination Of Working Wavelength (λMax)mentioning

confidence: 99%

Formulation, Development and Evaluation of Fast Dissolving Oral Film of a Atenolol Drug and validation by RP-HPLC Method using ICH Q2 guidelines

Khandare

Wagh²

2019

J. Drug Delivery Ther.

View full text Add to dashboard Cite

show abstract

“…Few methods based on HPLC technique were reported to quantify ETC, EVR and TNF combination, (Devrukhakar et al, 2013;I H T Guideline, 2005) , (Ramaswamy and Dhas, 2018) , (Palavan et al, 2013) , (Rezaei et al, 2019) , (Raju et al, 2008) , (Varma et al, 2014) , Atlas et al (2016) . UPLC is a signi icant laboratory technique that reduces costs and improves the analytical performance needed to develop and validate the process.…”

Section: Introductionmentioning

confidence: 99%

Stability indicating UPLC method to quantify Emtricitabine, Tenofovir, and Efavirenz simultaneously in tablets: Method establishment

Sravanthi¹,

Madhavi²

2020

ijrps

View full text Add to dashboard Cite

An easy, precise, specific, and accurate UPLC method for the quantification of emtricitabine (ETC), tenofovir (TFR), and efavirenz (EVR) in their tablet dosage form was developed and validated. ETC, TFR, and EVR were separated and estimated using Waters UPLC with HSS C18 (100 × 3 mm, 1.7 μ) column. The mobile phase was 0.01 N potassium dihydrogen phosphate buffer (pH 4.5) and acetonitrile (40:60, vol/vol). The elution of ETC, TFR, and EVR was achieved using flow rate at 0.4 ml/min and detected at 265 nm using a photodiode array detector. The detector response was linear from 75 to 450 μg/ml for TNF, 50 to 300 μg/ml for ETC, and 150 to 900 μg/ml for EVR. The limit of detection and limit of quantification were 0.601 µg/ml and 1.82 µg/ml, 0.330 µg/ml and 0.100 µg/ml, 0.911 µg/ml and 2.76 µg/ml for TNF, ETC and EVR respectively. Validation was carried out in compliance with ICH guidelines. It was noticed that all validation parameters were inside the permissible range.

show abstract

“…Literature indicates spectrophotometry [5][6][7][8][9][10][11] , HPLC [12][13][14][15] , HPTLC 16 and LC/MS/MS 17 methods for determination of TDF individually and in combination with other drugs in pharmaceutical formulations, drug substance, and biological matrices. Similarly for EMT individually and in combination with other drugs by UV 18,19 , HPLC in pharmaceutical formulations, drug substance and biological matrices [20][21][22][23][24][25] , HPTLC, LC/MS/MS 26 and stability indicating liquid chromatographic methods 27 were reported. A detailed literature survey for RPV revealed that few analytical methods are available using spectrophotometric 28 , HPLC 29 and HPTLC 30 , individually.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of Stability-indicating HPLC-DAD method for simultaneous determination of Emtricitabine, Rilpivirine, and Tenofovir Alafenamide in bulk and their Pharmaceutical dosage forms

Saidulu¹,

Mastanamma²,

Suresh³

et al. 2018

IJCTR

View full text Add to dashboard Cite

A simple and rapid high performance liquid chromatographic method was developed and validated for simultaneous estimation of Emtricitabine(EMT), Rilpivirine (RPV), and Tenofovir alafenamide fumarate(TAF)in bulk active pharmaceutical ingredients & its tablet formulation. The method was established using Agilent C18 (250 × 4.6 mm, i.d., 5 μm) column, mobile phase consisting of 0.1%Formic acid: Acetonitrile (65:35%, v/v) at a flow rate of 1 mL/min with isocratic elution, injecting 20 µL sample into the chromatographic system. The eluted compounds were detected by using PDA detector at detection wavelength of 250 nm and temperature was maintained at 30 °C. Retention times of Reference Standard Emtricitabine, Rilpivirine, and Tenofovir alafenamide was found to be 2.90, 4.34, 6.58mins respectively. The calibration curve was plotted over the concentration range 4-20 g/mL for EMT, 2-10 g/mL of RPV and 1-5 g/mL of TAF.The recoveries for EMT, RPV and TAF were found to be 99.12, 99.38, and 99.18%, respectively. All the validation parameters results were obtained with in acceptance limit.Developed method was subjected to forced degradation studies under specified conditions, which meets the required criteria. The present method was specific, sensitive, reproducible, precise, rapid and simple.

show abstract

A Validated Stability-Indicating RP-HPLC Method for the Simultaneous Determination of Tenofovir, Emtricitabine, and a Efavirenz and Statistical Approach to Determine the Effect of Variables

Cited by 20 publications

References 17 publications

Formulation, Development and Evaluation of Fast Dissolving Oral Film of a Atenolol Drug and validation by RP-HPLC Method using ICH Q2 guidelines

Formulation, Development and Evaluation of Fast Dissolving Oral Film of a Atenolol Drug and validation by RP-HPLC Method using ICH Q2 guidelines

Stability indicating UPLC method to quantify Emtricitabine, Tenofovir, and Efavirenz simultaneously in tablets: Method establishment

Development and Validation of Stability-indicating HPLC-DAD method for simultaneous determination of Emtricitabine, Rilpivirine, and Tenofovir Alafenamide in bulk and their Pharmaceutical dosage forms

Contact Info

Product

Resources

About