Evidence mapPaperPMID 40485170Full record

ArticleBiomedical chromatography : BMC2025

Optimization and Validation of a High-Performance Liquid Chromatography (HPLC-UV) Method for Quantification of α-Lipoic Acid in Cyclodextrins Complex for Ocular Delivery.

Phuong Linh Ta, Lucia Bernat-Just, Adrián M Alambiaga-Caravaca, Vicent Rodilla, Alicia López-Castellano, Francisco Bosch-Morell

Abstract read
In one paragraph

Article in Biomedical chromatography : BMC, 2025. 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
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

1 citing paper in PubMed.

  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

6 authors.

Phuong Linh TaDepartment of Biomedical Sciences, School of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Alfara del Patriarca, Valencia, Spain.ORCID https://orcid.org/0000-0002-2933-1108
Lucia Bernat-JustDepartment of Pharmacy, School of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Alfara de Patriarca, Valencia, Spain.
Adrián M Alambiaga-CaravacaDepartment of Pharmacy, School of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Alfara de Patriarca, Valencia, Spain.
Vicent RodillaDepartment of Pharmacy, School of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Alfara de Patriarca, Valencia, Spain.ORCID https://orcid.org/0000-0001-9460-7505
Alicia López-CastellanoDepartment of Pharmacy, School of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Alfara de Patriarca, Valencia, Spain.
Francisco Bosch-MorellDepartment of Biomedical Sciences, School of Health Sciences, Universidad Cardenal Herrera-CEU, CEU Universities, Alfara del Patriarca, Valencia, Spain.

Funding

Fundación Universitaria San Pablo CEU-Santander FUSP-PPC-22-063Generalitat Valenciana CIAICO/2022/198
6 · The paper itself

Abstract

Alpha-lipoic acid (ALA) is a natural antioxidant with therapeutic potential, but no method currently quantifies ALA in ocular structures. This study utilizes beta-cyclodextrins (β-CD) and (2-hydroxypropyl)-β-cyclodextrins (HP-β-CD) to enhance ALA solubility and stability in 1:1 M ratio. This study aims to optimize and validate a method for quantifying ALA in CD complexes using high-performance liquid chromatography with ultraviolet detection (HPLC-UV) and to perform a diffusion study to evaluate ALA's permeability in ocular tissue. The HPLC method employed a C18 column (150 × 4.6 mm, 5 μm particle size) with an isocratic mobile phase of acetonitrile and water (50:50, v/v) at pH 4.0, a flow rate of 1 mL/min, detected ALA after 4.8 min at a wavelength of 334 nm. Validation of the method was conducted according to the ICH guideline M10 on bioanalytical method validation. The stability study revealed that better stability was obtained for ALA in β-CD inclusion in comparison with HP-β-CD. The ex vivo study using Franz diffusion cells was performed to confirm that ALA was able to permeate through the cornea and sclera via ocular administration. This accurate and precise HPLC-UV method paves the way for future research into ALA's potential to alleviate ocular conditions. SUMMARY: This study optimized and validated a precise and accurate HPLC-UV method for quantifying ALA in CD complexes, following ICH guideline M10 on bioanalytical method validation. Stability studies revealed that β-CD complexes provided better thermal and solubility stability for ALA compared to HP-β-CD complexes. The ex vivo diffusion study confirmed that ALA successfully permeated the cornea and sclera via ocular administration. The validated method lays the groundwork for future research on ALA's potential to alleviate complications associated with ocular diseases.

Indexed as

CyclodextrinsThioctic AcidAdministration, OphthalmicAnimalsChromatography, High Pressure LiquidDrug StabilityLimit of DetectionLinear ModelsReproducibility of ResultsCyclodextrinsThioctic Acidalpha‐lipoic acidcyclodextrinsex vivo diffusion studiesHPLC‐ UVocular drug deliveryvalidation method

Identifiers

PMID40485170
PMCPMC12146685

What Socratic holds

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Registered trials

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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 Socratic graph.