Evidence map›Paper›PMID 38497721›Full record

ArticleBioanalysis2024

Hamdi Nsairat, Ali Al-Samydai, Mohamed El-Tanani, Ashok K Shakya, Somaya Ahmad, Shorouq Alsotari, Walhan Alshaer, Ammar Shanneir, Munib M Saket, Tawfiq A Arafat

Abstract readValidation Study
In one paragraph

Article in Bioanalysis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Hamdi NsairatPharmacological and Diagnostic Research Center, Faculty of Pharmacy, Al-Ahliyya Amman University, Amman, 19328, Jordan.ORCID 0000-0001-5916-5879
Ali Al-SamydaiPharmacological and Diagnostic Research Center, Faculty of Pharmacy, Al-Ahliyya Amman University, Amman, 19328, Jordan.ORCID 0000-0003-0093-2310
Mohamed El-TananiPharmacological and Diagnostic Research Center, Faculty of Pharmacy, Al-Ahliyya Amman University, Amman, 19328, Jordan.ORCID 0000-0002-4735-5445
Ashok K ShakyaPharmacological and Diagnostic Research Center, Faculty of Pharmacy, Al-Ahliyya Amman University, Amman, 19328, Jordan.ORCID 0000-0002-2387-6940
Somaya AhmadPharmacological and Diagnostic Research Center, Faculty of Pharmacy, Al-Ahliyya Amman University, Amman, 19328, Jordan.
Shorouq AlsotariCell Therapy Center, University of Jordan, Amman, 11942, Jordan.
Walhan AlshaerCell Therapy Center, University of Jordan, Amman, 11942, Jordan.ORCID 0000-0003-2946-7328
Ammar ShanneirHikma Pharmaceuticals, Amman, Jordan.
Munib M SaketDepartment of Pharmaceutical and Chemical Engineering, School of Applied Medical Sciences, German Jordanian University, PO Box 35247 Amman, 11180, Jordan.
Tawfiq A ArafatJordan Center for Pharmaceutical Research, PO Box 950435, Amman, 11195, Jordan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This study was conducted to compare dissolution profiles of four Jordanian registered sildenafil (SDF) products to the originator. Dissolution samples were analyzed utilizing a validated and stability-indicating HPLC method in human plasma. Validation was performed for specificity, linearity, limit of detection, lower limit of quantification, precision, trueness and stability. SDF was extracted from plasma samples using liquid-liquid extraction. The analysis was performed utilizing isocratic elution on C18 column with 1.0 ml/min flow rate. The regression value was ∼0.999 over 3 days with drug recovery between 86.6 to 89.8%with 10 ng/ml lower limit of quantitation. This method displayed a good selectivity of SDF with improved stability under various conditions. The method was used for SDF quantification in dissolution medium. Similarity factors for local products varied according to the used mediums, but all SDF local products passed the dissolution

Indexed as

Sildenafil CitrateChromatography, High Pressure LiquidDrugs, GenericDrug StabilityHumansJordanLimit of DetectionSolubilityDrugs, GenericSildenafil CitrateAGREE scoredissolutionextractionHPLCisocratic elutionplasmasildenafilsustainabilityvalidation

Identifiers

PMID38497721
PMCPMC11235137

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.