https://doi.org/10.15255/KUI.2025.035
Published: Kem. Ind. 75 (7-8) (2026) 365–374
Paper reference number: KUI-35/2025
Paper type: Original scientific paper
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Evaluation of the Solubility Profiles of Hypolipidemic Drugs

N. Turković, B. Ivković, J. Šljivić, J. Savić and M. Turković

Abstract

Hypolipidemic agents represent an important class of drugs used in the treatment of hyperlipoproteinemia. Statins are reversible, competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A reductase, ezetimibe selectively inhibits intestinal and biliary absorption of cholesterol by blocking Niemann-Pick C1-like protein, while fibrates act as agonists of the peroxisome proliferator-activated receptor alpha nuclear receptor. Drug solubility is a critical parameter influencing bioavailability and therapeutic efficacy, particularly in orally administered formulations. This is of special importance for hypolipidemic agents such as simvastatin, atorvastatin, and fenofibrate, which are widely used in the treatment of hyperlipidemia. In this study, an HPLC method was developed and validated for determining the solubility of these three drugs. Method validation confirmed specificity, linearity, and precision. Solubility was assessed in four media of varying pH values (1.2, 4.5, 6.8, and 7.4) at 37 °C, employing a Zorbax Eclipse C18 column (5 µm, 150 × 4.6 mm), with a mobile phase consisting of acetonitrile and 0.1 % phosphoric acid, and UV detection at 242 nm. The results enabled solubility characterisation based on the dose number, which, in combination with literature-derived logP (partition coefficient) values, facilitated the Biopharmaceutics Classification System (BCS) categorisation of the investigated drugs. These findings provide valuable guidance for the design of new pharmaceutical formulations containing simvastatin, atorvastatin, or fenofibrate, as well as the optimisation of existing ones.

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Keywords

hypolipidemic drugs, solubility, HPLC, BCS classification, bioavailability