Evidence map›Paper›PMID 34496481›Full record

ArticleTurkish journal of pharmaceutical sciences2021

Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Bictegravir, Emtricitabine, and Tenofovir Alafenamide Fumarate

Tanuja Attaluri, Ganapaty Seru, Satya Narayana Murthy Varanasi

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Article in Turkish journal of pharmaceutical sciences, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.2field-weighted citation impact, top 36% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 11 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 2 institutions in 1 country.

Tanuja AttaluriDepartment of Pharmaceutical Analysis and Quality Assurance, Gitam Institute of Pharmacy, GITAM (Deemed to be University), Rushikonda, Visakhapatnam, IndiaORCID 0000-0001-7627-2625
Ganapaty SeruDepartment of Pharmaceutical Analysis and Quality Assurance, Gitam Institute of Pharmacy, GITAM (Deemed to be University), Rushikonda, Visakhapatnam, IndiaORCID 0000-0003-0831-7275
Satya Narayana Murthy VaranasiDr. Reddy's Laboratories, Hyderabad, IndiaORCID 0000-0002-8960-1202
GITAM University · INDr. Reddy's Laboratories (India) · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objectives: The focal intent of the current research work is to develop and validate a novel and reliable stability-indicating reverse-phase high performance liquid chromatographic method for the simultaneous estimation of a few anti-retrovirals, i.e., bictegravir, emtricitabine, and tenofovir alafenamide fumarate (AF). Materials and Methods: The novel method employs inertsil octyldecylsilyl C18 (4.6×250 mm, 5 mm) using 0.2% triethylamine buffer and methanol in a ratio of 40:60% (v/v) as the mobile phase to attain optimal elution. The detection wavelength was 260 nm with a 1.2 mL/min flow rate and a 20 μL injection volume. Results: The linearity ranges for bictegravir, emtricitabine and tenofovir AF were 25-125 μg/mL, 100-500 μg/mL, and 12.5-62.5 μg/mL, respectively. The retention times for bictegravir, emtricitabine, and tenofovir AF were found to be 5.998 min, 2.805 min, and 4.537, min respectively. The percent recoveries of bictegravir, emtricitabine, and tenofovir AF were within the range of 98-102% w/w. Conclusion: The novel method was successfully validated as per International Conference on Harmonization guidelines. In forced degradation studies, emtricitabine was found to be sensitive to thermal conditions; bictegravir and tenofovir AF, to oxidative conditions. The developed method is economical and reliable for routine analysis concerning all validated parameters.

Indexed as

Bictegraviremtricitabineforced degradation studiesRP-HPLCtenofovir AFvalidation

Identifiers

PMID34496481
PMCPMC8430401
OpenAlexW3196974939

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.