Journal of Food and Pharmaceutical Science
Vol 13, No 4 (2025): J.Food.Pharm.Sci

Ultra-High Performance Liquid Chromatography Method Validation for Micro-dissolution Analysis of Ketoconazole in Alginate-Acacia Gum Composite Capsules

Lumakso, Fajar Aji (Unknown)
Annisa, Viviane (Unknown)
Cermenda, Riska (Unknown)
Chabib, Lutfi (Unknown)



Article Info

Publish Date
19 Dec 2025

Abstract

Ketoconazole, a BCS Class 2 antifungal drug, has good absorption but suffers from low solubility and poor bioavailability. To address this, a natural polymer-based matrix of alginate and acacia gum was formulated to enhance dissolution. This study aimed to validate a Ultra High Performance Liquid Chromatography method for analyzing ketoconazole content in micro-dissolution testing of capsule formulations. The method employed a C18 column with a mobile phase of acetonitrile:WFI (0.15% TEA, pH 3.5; 50:50) at 1 mL/min and detection at 265 nm. Validation demonstrated compliance with selectivity, linearity (r = 0.9996), sensitivity (LoD 6.51 µg/mL; LoQ 19.74 µg/mL), accuracy (99.6–101.3%), and precision (<2%, except one interday result at 2.08%). Micro-dissolution testing showed sustained ketoconazole release, exceeding 100% within 240 minutes. Data modeling (performed using DDSolver) indicated comparable fit for the Higuchi (R²_adj = 0.96) and Korsmeyer (R²_adj = 0.93) models, suggesting diffusion-controlled release of ketokonazole. The validated UHPLC method is suitable for micro-dissolution studies, and the alginate-acacia gum formulation effectively modulates drug release.

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Journal Info

Abbrev

jfps

Publisher

Subject

Biochemistry, Genetics & Molecular Biology Chemistry Immunology & microbiology Medicine & Pharmacology

Description

FOCUS AND SCOPE Journal of Food and Pharmaceutical Sciences offers scientists, researchers, and other professionals to share knowledge of scientific advancements. The journal will publish original research articles, review articles, short communication, and letter to editor. The area of focus should ...