ReviewHeliyon2021
Choices of chromatographic methods as stability indicating assays for pharmaceutical products: A review.
Review in Heliyon, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 60 citations in OpenAlex.
- Chromatographic Methods Developed for the Quantification of Quercetin Extracted from Natural Sources: Systematic Review of Published Studies from 2018 to 2022.Molecules (Basel, Switzerland) · 2023Pooled it
- Stability-Indicating HPLC Method for Simultaneous Determination of Sulfadimethoxine and Ormetoprim in an Oral Solution.ACS omega · 2026Article
- Stability Assessment of Compounded Niaprazine Oral Solutions to Support an Evidence-Based Beyond-Use Date.Pharmaceutics · 2026Article
- Article
- Development and Validation of RP-HPLC Method forACS omega · 2025Article
- Detection of lamivudine using liquid-surface-enhanced Raman spectroscopy.RSC advances · 2025Article
- A stability-illustrating HPLC-DAD method for assessment of two veterinary anti-parasitic drugs: appraisal of the method's greenness and blueness.BMC chemistry · 2025Article
- Phytochemical Analysis and Biological Activities of Flavonoids and Anthraquinones fromPlants (Basel, Switzerland) · 2025Article
- A Newly Validated HPLC-DAD Method for the Determination of Ricinoleic Acid (RA) in PLGA Nanocapsules.Pharmaceuticals (Basel, Switzerland) · 2024Article
- Analysis of Antioxidant Compounds inMolecules (Basel, Switzerland) · 2024Article
- Puerarin-A Promising Flavonoid: Biosynthesis, Extraction Methods, Analytical Techniques, and Biological Effects.International journal of molecular sciences · 2024Review
- Validated chromatographic methods for determination of teriflunomide and investigation of its intrinsic stability.BMC chemistry · 2024Article
- In-depth analysis of lupeol: delving into the diverse pharmacological profile.Frontiers in pharmacology · 2024Review
- Validation of an HPLC-DAD Method for Quercetin Quantification in Nanoparticles.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Natural alternatives from your garden for hair care: Revisiting the benefits of tropical herbs.Heliyon · 2023Review
- Advanced visual sensing techniques for on-site detection of pesticide residue in water environments.Heliyon · 2023Review
- A Review of Methods for Removal of Ceftriaxone from Wastewater.Journal of xenobiotics · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Stability indicating assay describes a technique which is used to analyse the stability of drug substance or active pharmaceutical ingredient (API) in bulk drug and pharmaceutical products. Stability indicating assay must be properly validated as per ICH guidelines. The important components in a stability indicating assay include sensitivity, specificity, accuracy, reliability, reproducibility and robustness. A validated assay is able to measure the concentration changes of drug substance/API with time and make reliable estimation of the quantity of the degradation impurities. The drug substance is separated and resolved from the impurities. Pros and cons of HPLC, GC, HPTLC, CE and SFC were discussed and reviewed. Stability indicating assay may consist of the combination of chromatographic separation and spectroscopic detection techniques. Hyphenated system could demonstrate parallel quantitative and qualitative analysis of drug substances and impurities. Examples are HPLC-DAD, HPLC-FL, GC-MS, LC-MS and LC-NMR. The analytes in the samples are separated in the chromatography while the impurities are chemically characterised by the spectroscopy in the system. In this review, various chromatographic methods which had been employed as stability indicating assays for drug substance and pharmaceutical formulation were systematically reviewed, and the application of hyphenated techniques in impurities characterisation and identification were also discussed with supporting literatures.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.